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Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment (PRECEPT)

15 de enero de 2016 actualizado por: Amgen

Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer

The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

116

Fase

  • Fase 2

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:

  • Diagnosis of metastatic adenocarcinoma of the colon or rectum
  • Available paraffin-embedded tumor tissue
  • Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
  • Measurable disease
  • Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria:

  • Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
  • Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
  • Prior irinotecan therapy, anti epidermal growth factor receptor (EGFr) therapy, or vaccine for the treatment of mCRC
  • CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
  • Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1
  • Clinically significant cardiovascular disease
  • History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
  • Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to Day 1 of Cycle 1
  • Any significant bleeding ≤ 6 weeks prior to Day 1 of Cycle 1, per the investigator's judgement
  • Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
  • Any co-morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
  • Major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤ 4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery and have no significant complications

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Panitumumab plus FOLFIRI
Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
Biológico: Panitumumab
Administrado por infusión intravenosa
Otros nombres:
  • Vectibix
Droga: FOLFIRI
Quimioterapia consistente en irinotecán con infusión de 5-fluorouracilo y leucovorina. El régimen de dosificación recomendado y la administración de FOLFIRI se basaron en el estándar de atención local, el prospecto de cada producto y las pautas institucionales.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response Rate at Weeks 17 and 25
Periodo de tiempo: Week 17 and Week 25
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
Week 17 and Week 25
Best Response During Second-Line Treatment
Periodo de tiempo: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.

Objective response rate is defined as the percentage of participants with a best response of complete response or partial response based on investigator review of scans using modified RECIST criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no post-baseline radiographic tumor assessment(s) were considered non-responders.

CR: disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or PD and no new lesions.
Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Progression-free Survival Rate at Weeks 17 and 25
Periodo de tiempo: Week 17 and Week 25

The progression-free survival rate is defined as the Kaplan-Meier (KM) estimator of progression-free survival at Week 17 and Week 25 reported as the probability of being event (disease progression or death)-free. Tumor assessments were evaluated by the investigator according to modified RECIST criteria.

PD: At least a 20% increase in the size of target lesions since the treatment started or at least a 25% increase in the size of non-target lesions and the lesion(s) measure ≥ 10 mm, or the appearance of any new lesions. Participants who withdraw from the study prior to completion of Week 17 or 25 radiographic tumor assessments were censored at the last evaluable tumor assessment.
Week 17 and Week 25
Progression-free Survival Time
Periodo de tiempo: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Progression-free survival time was defined as the time from Study Day 1 to the date of disease progression (based on investigator assessment) or the date of death due to any cause. Participants who terminated from the study early (eg, prior to disease progression due to fully withdrawn informed consent) were censored at their last tumor assessment.
From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Disease Control Rate at Weeks 17 and 25
Periodo de tiempo: Week 17 and Week 25
The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST criteria as assessed by the investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.
Week 17 and Week 25
Duration of Response
Periodo de tiempo: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Duration of response is defined as the time from the date of first response to the date of first progression of disease during second-line treatment (as evaluated by the investigator) or death (if the death was due to disease progression but not detected earlier) in the subset of participants who responded (CR or PR, as evaluated by the investigator). Duration of response was analyzed using Kaplan-Meier methods; participants who responded but did not progress while on study were censored at the date of last tumor assessment.
Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Overall Survival
Periodo de tiempo: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Overall survival is defined as as the number of days from Study Day 1 to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were lost to follow-up or who had not died at the end of the study (52 weeks after the last participant was enrolled) were censored at the date of last contact.
From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Time to Treatment Failure
Periodo de tiempo: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Time to failure of second-line treatment is defined as the time from study Day 1 to the date of the earliest of the following events: end of second-line therapy due to any reason except for complete response and curative surgery; progressive disease; or death due to any cause. Time to treatment failure was analyzed using Kaplan-Meier methods; participants who did not discontinue second-line treatment or discontinue due to complete response or curative surgery, who were still alive, and who did not have disease progression were censored at the date of the last contact.
Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Time to Progression
Periodo de tiempo: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Time to progression is defined as the time from study Day 1 to the date of observed disease progression. Time to progression was analyzed using Kaplan-Meier methods; participants who did not have disease progression were censored at the date of last evaluable tumor assessment.
From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Time to Response
Periodo de tiempo: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Time to response of second-line treatment is defined as the time from study Day 1 to the date of first documentation of CR or PR, calculated for those participants with an objective tumor response of CR or PR.
Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Adverse Events
Periodo de tiempo: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
The severity of adverse events (AEs) was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, except for panitumumab related skin toxicities, where Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The relationship of each adverse event to the panitumumab and/or FOLFIRI regimen was assessed by the investigator. A serious adverse event was defined as an adverse event that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.
From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
Number of Participants With Grade 4 Laboratory Toxicities
Periodo de tiempo: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
Laboratory toxicities were graded according to CTCAE version 3.
From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
Number of Participants Who Developed Antibodies to Panitumumab
Periodo de tiempo: Prior to first dose and 28 days after the last dose of second-line treatment
The immunogenicity of panitumumab was evaluated using 2 different screening immunoassays for the detection of anti-panitumumab antibodies: an acid dissociation bridging enzyme-linked immunosorbent assay (ELISA; detecting high-affinity antibodies) and a Biacore® biosensor immunoassay (detecting both high and low-affinity antibodies). When either of the 2 screening assays yielded a positive result, that particular sample was subjected to an in vitro bioassay for the detection of neutralizing antibodies.
Prior to first dose and 28 days after the last dose of second-line treatment

Colaboradores e Investigadores

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

Patrocinador

Amgen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

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 noviembre de 2006

Finalización primaria (Actual)

1 de enero de 2009

Finalización del estudio (Actual)

1 de octubre de 2010

Fechas de registro del estudio

Enviado por primera vez

12 de diciembre de 2006

Primero enviado que cumplió con los criterios de control de calidad

13 de diciembre de 2006

Publicado por primera vez (Estimar)

14 de diciembre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de febrero de 2016

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

15 de enero de 2016

Última verificación

1 de enero de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20060277

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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