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

Colorectal Cancer Clinical Trial

Official title:

A Randomized Phase II Study of Bevacizumab/mFOLFOX6 Versus Bevacizumab/FOLFIRI With Biomarker Stratification in Patients With Previously Untreated Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374425
• Other study ID #: ML25710
• Secondary ID: MAVERICC
• Status: Completed
• Phase: Phase 2
• First received: June 14, 2011
• Last updated: January 8, 2016
• Start date: August 2011
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This will be a randomized, open-label, multicenter, phase II study. The study population will consist of participants with first-line metastatic colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: July 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• Bevacizumab
Bevacizumab 5 milligram per kilogram (mg/kg) of body weight administered as intravenous infusion, every 2 weeks until disease progression or unacceptable toxicity.
• Irinotecan
Irinotecan 180 mg/m^2 administered as intravenous infusion over 2 hour, every 2 weeks until disease progression or unacceptable toxicity.
• 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.
• Oxaliplatin
Oxaliplatin 85 mg/m^2 administered as intravenous infusion over 2 hour, every 2 weeks until disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Estonia,  Ireland,  Norway,  Portugal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) As Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1		Randomization (baseline) up to documented disease progression or death on study, whichever occurs first (maximum up to approximately 2.2 years)	No
Secondary	Overall Survival (OS)		Time from randomization (baseline) to death from any cause (maximum up to approximately 2.2 years)	No
Secondary	Percentage of Participants With Objective Response (OR) Determined Using RECIST, Version 1.1		Baseline up to approximately 2.2 years	No