A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab
Phase 3
Withdrawn
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT01338558
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Adult patients >/= 18 years of age
- Histologically confirmed adenocarcinoma of the colon or rectum
- Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria
- Tumour tissue sample available for assessment of K-RAS and BRAF genes
- Prior radiotherapy must have been completed 4 weeks before randomization
- Adequate bone marrow, kidney and liver function
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion Criteria
- Previous chemotherapy for metastatic disease
- Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization
- Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors
- Clinical or radiographic evidence of brain metastases
- Clinically significant cardiovascular disease or disorder
- History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours
- HIV, hepatitis B or C infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description K-RAS native A bevacizumab [Avastin] - K-RAS mutated mFOLFOX6 - K-RAS native B mFOLFOX6 - K-RAS native A mFOLFOX6 - K-RAS mutated bevacizumab [Avastin] - K-RAS native B cetuximab -
- Primary Outcome Measures
Name Time Method Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria up to 4 years
- Secondary Outcome Measures
Name Time Method Objective response rate 4 years Safety: Incidence of adverse events 4 years Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30) up to 4 years Overall survival up to 4 years Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms up to 4 years