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

Conditions

• Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 5-Fluorouracil — DRUG
  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.
• Bevacizumab — DRUG
  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.
• Irinotecan — DRUG
  Irinotecan 180 mg/m\^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
• Leucovorin — DRUG
  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.
• Oxaliplatin — DRUG
  Oxaliplatin 85 mg/m\^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
• Capecitabine — DRUG
  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.

Study Details

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.

Key Dates

Start date

Aug 31, 2011

Status verified

Jun 2016

Primary completion

May 31, 2015

Completion

Jul 31, 2015

Study Design

Enrollment

376 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall) ]

Locations (65)

Find similar trials in Birmingham, AL

Related Studies

• ColoCare Study - Colorectal Cancer Cohort
  Recruiting · University of Utah · Los Angeles, California
• Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
  PHASE1/PHASE2 · Recruiting · Lumicell, Inc. · Boston, Massachusetts
• A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
  PHASE1/PHASE2 · Recruiting · Merus B.V. · La Jolla, California
• Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
  PHASE1/PHASE2 · Recruiting · Anwaar Saeed · Westwood, Kansas