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

• Status: Withdrawn
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Cetuximab

Criteria

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