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Study of Bevacizumab + mFOLFOX6 Versus Bevacizumab + FOLFIRI With Biomarker Stratification in Participants With Previously Untreated Metastatic Colorectal Cancer (mCRC) (MAVERICC)

30 de junio de 2016 actualizado por: Genentech, Inc.

MAVERICC (Marker Evaluation for Avastin Research in CRC): A Randomized Phase II Study of Bevacizumab+mFOLFOX6 Vs. Bevacizumab+FOLFIRI With Biomarker Stratification in Patients With Previously Untreated Metastatic Colorectal Cancer

This will be a randomized, open-label, multicenter, Phase II study with primary objectives to assess whether expression of select chemotherapy markers is associated with progression-free survival (PFS) in participants treated with bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI). The study population will consist of participants with first-line mCRC.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

376

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1Z2
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72205-7199
    • California
      • Bellflower, California, Estados Unidos, 90706
      • Duarte, California, Estados Unidos, 91010
      • Fountain Valley, California, Estados Unidos, 92708
      • Fresno, California, Estados Unidos, 93720
      • Hayward, California, Estados Unidos, 94545
      • Los Angeles, California, Estados Unidos, 90033
      • Oakland, California, Estados Unidos, 94611
      • Pleasant Hill, California, Estados Unidos, 94523
      • Roseville, California, Estados Unidos, 95661
      • Sacramento, California, Estados Unidos, 95817
      • Sacramento, California, Estados Unidos, 95825
      • San Francisco, California, Estados Unidos, 94115
      • San Jose, California, Estados Unidos, 95119
      • Santa Clara, California, Estados Unidos, 95051
      • South San Francisco, California, Estados Unidos, 94080
      • Vallejo, California, Estados Unidos, 94589
      • Walnut Creek, California, Estados Unidos, 94596
    • Colorado
      • Denver, Colorado, Estados Unidos, 80218
    • Connecticut
      • Stamford, Connecticut, Estados Unidos, 06902
      • Trumbull, Connecticut, Estados Unidos, 06611
    • Florida
      • Hollywood, Florida, Estados Unidos, 33021
      • Jacksonville, Florida, Estados Unidos, 32256
      • Miami, Florida, Estados Unidos, 33136
      • Port Saint Lucie, Florida, Estados Unidos, 34952
    • Idaho
      • Boise, Idaho, Estados Unidos, 83712
    • Illinois
      • Joliet, Illinois, Estados Unidos, 60435
      • Maywood, Illinois, Estados Unidos, 60153
      • Peoria, Illinois, Estados Unidos, 61615
    • Indiana
      • Goshen, Indiana, Estados Unidos, 46526
      • Indianapolis, Indiana, Estados Unidos, 46237
      • Terre Haute, Indiana, Estados Unidos, 47802
    • Kansas
      • Fairway, Kansas, Estados Unidos, 66205
    • Kentucky
      • Elizabethtown, Kentucky, Estados Unidos, 42791
    • Maine
      • Scarborough, Maine, Estados Unidos, 04074
    • Massachusetts
      • Burlington, Massachusetts, Estados Unidos, 01805
    • Montana
      • Billings, Montana, Estados Unidos, 59102
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68506
    • New Jersey
      • Cherry Hill, New Jersey, Estados Unidos, 08003
      • Manasquan, New Jersey, Estados Unidos, 08736
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87131-5636
      • Albuquerque, New Mexico, Estados Unidos, 87106
      • Albuquerque, New Mexico, Estados Unidos, 87110
      • Farmington, New Mexico, Estados Unidos, 87401
      • Las Cruces, New Mexico, Estados Unidos, 88011
      • Santa Fe, New Mexico, Estados Unidos, 87505
    • New York
      • Rochester, New York, Estados Unidos, 14642
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
      • Greensboro, North Carolina, Estados Unidos, 27403
      • High Point, North Carolina, Estados Unidos, 27262
      • Washington, North Carolina, Estados Unidos, 27889
      • Winston-salem, North Carolina, Estados Unidos, 27103
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43219
      • Toledo, Ohio, Estados Unidos, 43623
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73142
    • Pennsylvania
      • Dunmore, Pennsylvania, Estados Unidos, 18512
      • Media, Pennsylvania, Estados Unidos, 19063
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
      • Pittsburgh, Pennsylvania, Estados Unidos, 15212
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29414
    • Texas
      • Corpus Christi, Texas, Estados Unidos, 78404
      • Houston, Texas, Estados Unidos, 77090
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792
      • Wauwatosa, Wisconsin, Estados Unidos, 53226
  • Estonia
      • Tallinn, Estonia, 13419
      • Tartu, Estonia, 51014
  • Irlanda
      • Cork, Irlanda
      • Dublin, Irlanda, 24
      • Galway, Irlanda
  • Noruega
      • Oslo, Noruega, 0407
  • Portugal
      • Coimbra, Portugal, 3000-075
      • Lisboa, Portugal, 1649-035
      • Porto, Portugal, 4200-072
  • Suiza
      • Aarau, Suiza, 5000
      • Basel, Suiza, 4031
      • Luzern, Suiza, 6004
      • Zürich, Suiza, 8063

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Histologically or cytologically confirmed colorectal cancer (CRC) with at least one measurable metastatic lesion by RECIST Version 1.1
  • Archival tumor tissue sample must be requested and available prior to study entry. If no archival tumor tissue sample is available, a fresh biopsy tissue sample must be obtained but should be discussed first with the medical monitor. A copy of the local pathology report must be submitted along with the specimens.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Participants with treated brain metastases are eligible for study participation. Participants may not receive ongoing treatment with steroids at Screening. Anticonvulsants (at stable dose) are allowed. Treatment for brain metastases may be whole-brain radiotherapy, radiosurgery, neurosurgery, or a combination as deemed appropriate by the treating physician. Radiotherapy and stereotactic radiosurgery must be completed at least 28 days prior to randomization.
  • Female participants should not be pregnant or breastfeeding. Female participants with childbearing potential should agree to use effective, non-hormonal means of contraception during the study and for a period of at least 6 months following the last administration of study drugs. Female participants with an intact uterus (unless amenorrheic for the last 24 months) must have a negative serum pregnancy test within 7 days prior to randomization into the study.
  • Male participants must agree to use effective contraception during the study and for a period of at least 6 months following the last administration of study drugs, even if they have been surgically sterilized.

Exclusion Criteria:

  • Any prior systemic treatment for mCRC
  • Adjuvant chemotherapy for CRC completed <12 months
  • Evidence of Gilbert's syndrome or of homozygosity for the UGT1A1*28 allele
  • Known positivity for human immunodeficiency virus (HIV)
  • Malignancies other than mCRC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
  • Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
  • Clinically detectable third-space fluid collections that cannot be controlled by drainage or other procedures prior to study entry
  • Treatment with any other investigational agent, or participation in another investigational drug trial within 28 days prior to randomization

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Bevacizumab + mFOLFOX6
Participants will receive bevacizumab plus mFOLFOX6 by intravenous (IV) infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity. Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin, with bevacizumab continued in 3-week cycles.
Droga: 5-Fluorouracil
5-Fluorouracil 400 milligrams per meter-squared (mg/m^2) by IV bolus and subsequent 2400 mg/m^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Droga: Bevacizumab
Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity. If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine.
Otros nombres:
  • Avastin
Droga: Leucovorin
Leucovorin 400 mg/m^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Droga: Oxaliplatin
Oxaliplatin 85 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Droga: Capecitabine
Capecitabine 850 or 1000 mg/m^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.
Experimental: Bevacizumab + FOLFIRI
Participants will receive bevacizumab plus FOLFIRI by IV infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity. Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan, with bevacizumab continued in 3-week cycles.
Droga: 5-Fluorouracil
5-Fluorouracil 400 milligrams per meter-squared (mg/m^2) by IV bolus and subsequent 2400 mg/m^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Droga: Bevacizumab
Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity. If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine.
Otros nombres:
  • Avastin
Droga: Leucovorin
Leucovorin 400 mg/m^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
Droga: Capecitabine
Capecitabine 850 or 1000 mg/m^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.
Droga: Irinotecan
Irinotecan 180 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of largest diameters (LD) of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 millimeters (mm). Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
PFS According to RECIST Version 1.1 in Participants With High Vascular Endothelial Growth Factor (VEGF)-A Levels Versus Participants With Low VEGF-A Levels
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Overall Survival (OS)
Periodo de tiempo: From Baseline until death (maximum up to 45 months overall)
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death (maximum up to 45 months overall)
OS in Participants With High ERCC-1 Levels
Periodo de tiempo: From Baseline until death (maximum up to 45 months overall)
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death (maximum up to 45 months overall)
OS in Participants With Low ERCC-1 Levels
Periodo de tiempo: From Baseline until death (maximum up to 45 months overall)
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death (maximum up to 45 months overall)
OS in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Periodo de tiempo: From Baseline until death (maximum up to 45 months overall)
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death (maximum up to 45 months overall)
Percentage of Participants With Objective Response According to RECIST Version 1.1
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Objective response was defined as complete response (CR) or partial response (PR) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Disease Control According to RECIST Version 1.1
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Disease control was defined as CR, PR, or stable disease (SD) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Liver Metastasis Resection
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)
Percentage of Participants With Complete Liver Metastasis Resection
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)
Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)
Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)
Percentage of Participants With Liver Metastasis Resection in Participants With Low ERCC-1 Levels
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)
Percentage of Participants With Complete Liver Metastasis Resection in Participants With Low ERCC-1 Levels
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)
Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)
Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)
PFS According to RECIST Version 1.1 in Participants With Wild-Type V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Versus Participants With Mutant KRAS
Periodo de tiempo: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)
OS in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Periodo de tiempo: From Baseline until death (maximum up to 45 months overall)
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death (maximum up to 45 months overall)
OS in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS
Periodo de tiempo: From Baseline until death (maximum up to 45 months overall)
Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.
From Baseline until death (maximum up to 45 months overall)
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Periodo de tiempo: From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.
From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)
Percentage of Participants With Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)
Percentage of Participants With Complete Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels
Periodo de tiempo: At time of resective surgery during study (maximum up to 45 months overall)
The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.
At time of resective surgery during study (maximum up to 45 months overall)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Genentech, Inc.

Investigadores

  • Director de estudio: Christiane Langer, M.D., Genentech, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2011

Finalización primaria (Actual)

1 de mayo de 2015

Finalización del estudio (Actual)

1 de julio de 2015

Fechas de registro del estudio

Enviado por primera vez

14 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2011

Publicado por primera vez (Estimar)

16 de junio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de agosto de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

30 de junio de 2016

Última verificación

1 de junio de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ML25710
  • 2011-004755-39 (Número EudraCT)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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