Study of Bevacizumab/mFOLFOX6 Versus Bevacizumab/Folfiri With Biomarker Stratification in Patients With Previously Untreated Metastatic Colorectal Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: June 14, 2011
Last updated: October 20, 2014
Last verified: October 2014
This will be a randomized, open-label, multicenter, phase II study. The study p opulation will consist of first-line metastatic colorectal cancer patients.

Condition Intervention Phase
Colorectal Cancer
Drug: FOLFIRI regimen
Drug: bevacizumab
Drug: mFOLFOX6
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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 RECIST, v1.1 [ Time Frame: Time from randomization (baseline) to documented disease progression or death on study, whichever occurs first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Time from randomization (baseline) to death from any cause ] [ Designated as safety issue: No ]
  • Objective response (OR) , as assessed by the investigator using RECIST, v1.1 [ Time Frame: Conducted at least 4 weeks apart (imaging every 6 weeks) ] [ Designated as safety issue: No ]

Enrollment: 377
Study Start Date: August 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab
Repeating intravenous infusion
Drug: mFOLFOX6
Repeating intravenous infusion
Experimental: B Drug: FOLFIRI regimen
Repeating intravenous infusion
Drug: bevacizumab
Repeating intravenous infusion


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

Inclusion Criteria:

  • Histologically or cytologically confirmed colorectal cancer (CRC) with at least one measurable metastatic lesion by RECIST, v1.1
  • Archival tumor tissue sample for ERCC-1 assessment (stratification) 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.
  • Patients with treated brain metastases are eligible for study participation. Patients 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 patients should not be pregnant or breast-feeding. Female patients 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 patients 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 patients 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 < 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 identifier: NCT01374425

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

No publications provided

Responsible Party: Genentech, Inc. Identifier: NCT01374425     History of Changes
Other Study ID Numbers: ML25710, MAVERICC
Study First Received: June 14, 2011
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 27, 2015