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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01374425
First received: June 14, 2011
Last updated: January 8, 2016
Last verified: January 2016
  Purpose
This will be a randomized, open-label, multicenter, phase II study. The study population will consist of participants with first-line metastatic colorectal cancer.

Condition Intervention Phase
Colorectal Cancer
Drug: 5-fluorouracil
Drug: Bevacizumab
Drug: Irinotecan
Drug: Leucovorin
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Bevacizumab/mFOLFOX6 Versus Bevacizumab/FOLFIRI With Biomarker Stratification in Patients With Previously Untreated Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Progression-free Survival (PFS) As Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 [ Time Frame: Randomization (baseline) up to documented disease progression or death on study, whichever occurs first (maximum up to approximately 2.2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Time from randomization (baseline) to death from any cause (maximum up to approximately 2.2 years) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Objective Response (OR) Determined Using RECIST, Version 1.1 [ Time Frame: Baseline up to approximately 2.2 years ] [ Designated as safety issue: No ]

Enrollment: 376
Study Start Date: August 2011
Study Completion Date: July 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab + FOLFIRI
Bevacizumab intravenous infusion followed by concomitant intravenous infusions of leucovorin and irinotecan, and thereafter an intravenous bolus and subsequent continuous intravenous infusion of 5-fluorouracil, every 2 weeks until disease progression or unacceptable toxicity.
Drug: 5-fluorouracil
5-fluorouracil 400 mg/m^2 intravenous bolus and subsequent 2400 mg/m^2 intravenous infusion over 46 hour, administered every 2 weeks until disease progression or unacceptable toxicity.
Drug: Bevacizumab
Bevacizumab 5 milligram per kilogram (mg/kg) of body weight administered as intravenous infusion, every 2 weeks until disease progression or unacceptable toxicity.
Other Name: Avastin
Drug: Irinotecan
Irinotecan 180 mg/m^2 administered as intravenous infusion over 2 hour, every 2 weeks until disease progression or unacceptable toxicity.
Drug: Leucovorin
Leucovorin 400 milligram per meter square (mg/m^2) or at dose deemed appropriate by investigator administered as intravenous infusion over 2 hour, every 2 weeks until disease progression or unacceptable toxicity.
Experimental: Bevacizumab + mFOLFOX6
Bevacizumab intravenous infusion followed by concomitant intravenous infusions of leucovorin and oxaliplatin, and thereafter an intravenous bolus and subsequent continuous intravenous infusion of 5-fluorouracil, every 2 weeks until disease progression or unacceptable toxicity.
Drug: 5-fluorouracil
5-fluorouracil 400 mg/m^2 intravenous bolus and subsequent 2400 mg/m^2 intravenous infusion over 46 hour, administered every 2 weeks until disease progression or unacceptable toxicity.
Drug: Bevacizumab
Bevacizumab 5 milligram per kilogram (mg/kg) of body weight administered as intravenous infusion, every 2 weeks until disease progression or unacceptable toxicity.
Other Name: Avastin
Drug: Leucovorin
Leucovorin 400 milligram per meter square (mg/m^2) or at dose deemed appropriate by investigator administered as intravenous infusion over 2 hour, every 2 weeks until disease progression or unacceptable toxicity.
Drug: Oxaliplatin
Oxaliplatin 85 mg/m^2 administered as intravenous infusion over 2 hour, every 2 weeks until disease progression or unacceptable toxicity.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed colorectal cancer (CRC) with at least one measurable metastatic lesion by Response Evaluation Criteria in Solid Tumors (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 breast-feeding. 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 amenorrhoeic 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 metastatic CRC
  • Adjuvant chemotherapy for CRC completed less than (<) 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 metastatic CRC 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374425

  Show 79 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Christiane Langer, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01374425     History of Changes
Other Study ID Numbers: ML25710  MAVERICC 
Study First Received: June 14, 2011
Last Updated: January 8, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bevacizumab
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Fluorouracil
Irinotecan
Oxaliplatin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2016