FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer

Genentech

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Placebo; Drug: leucovorin; Drug: bevacizumab [Avastin]; Drug: onartuzumab [MetMAb]; Drug: FOLFOX regimen; Drug: 5-FU

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01418222

GO27827

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.

Enrollment: 194 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Measurable disease by RECIST criteria
• Adequate organ system function, as defined by protocol

Exclusion criteria

• Prior systemic or radiation therapy for metastatic colorectal cancer
• Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease
• Previously untreated brain metastases
• History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• History of hematemesis or hemoptysis </= 1 months prior to study enrollment
• Significant cardiovascular disease or disorder
• History of abdominal fistula or gastrointestinal perforation </= 6 months prior to Day 1
• Positive for hepatitis B, hepatitis C or HIV infection
• Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer

Trial design

194 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: FOLFOX regimen

Drug: bevacizumab [Avastin]

Drug: onartuzumab [MetMAb]

Drug: 5-FU

Drug: leucovorin

B

Active Comparator group

Treatment:

Drug: FOLFOX regimen

Drug: bevacizumab [Avastin]

Drug: Placebo

Drug: 5-FU

Drug: leucovorin