Roche trials database

Trial information

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Withdrawn

Protocol number:

ML25686

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

A Randomized, Phase III Clinical Trial to Assess the Prognostic Value of Mutation Status of the K-RAS Gene in Treatment-Naïve Patients with Stage IV Metastatic Colorectal Cancer Treated with mFOLFOX6 in Combination with Avastin (Bevacizumab) or Cetuximab

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. Target sample size is 825.

Study phase:

III

Study type:

Interventional; Treatment; Randomized; Parallel; Safety/efficacy study

Conditions:

• Colorectal Cancer

Intervention type:

Drug

Intervention name:

bevacizumab [Avastin]

Primary outcome:

1. Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria Time frame: up to 4 years

Key secondary outcomes:

1. Overall survival Time frame: up to 4 years
2. Objective response rate Time frame: 4 years
3. Safety: Incidence of adverse events Time frame: 4 years
4. Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30) Time frame: up to 4 years
5. Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms Time frame: up to 4 years

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

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Trial registration date:

11.02.2011

Date last updated:

16.03.2011

This trial was conducted at the following locations:

Link to trial result