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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 giugno 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

376

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • 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.
Sperimentale: 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.
Altri nomi:
  • 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Genentech, Inc.

Investigatori

  • Direttore dello studio: Christiane Langer, M.D., Genentech, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2011

Completamento primario (Effettivo)

1 maggio 2015

Completamento dello studio (Effettivo)

1 luglio 2015

Date di iscrizione allo studio

Primo inviato

14 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2011

Primo Inserito (Stima)

16 giugno 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 agosto 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 giugno 2016

Ultimo verificato

1 giugno 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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