Colorectal Cancer
Conditions
Brief summary
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.
Interventions
DRUGleucovorin
Intravenous repeating dose
DRUGPlacebo
Intravenous repeating dose
DRUGbevacizumab [Avastin]
Intravenous repeating dose
DRUG5-FU
Intravenous repeating dose
DRUGFOLFOX regimen
Intravenous repeating dose
Intravenous repeating dose
Sponsors
SCRI Development Innovations, LLC
Genentech, Inc.
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria | up to 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (complete response + partial response) | up to 4 years |
| Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death | up to 4 years |
| Overall survival | up to 4 years |
| Safety: Incidence of adverse events | up to 4 years |
Countries
United States
Outcome results
None listed