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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01338558
• Collaborator: (none)
• Enrollment: 0
• Arms: 3
• Duration (Months): 47

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: bevacizumab [Avastin]; Drug: cetuximab; Drug: mFOLFOX6	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2011
• Anticipated Primary Completion Date: May 1, 2015
• Anticipated Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: K-RAS mutated	Drug: bevacizumab [Avastin]; 5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent; Drug: mFOLFOX6; Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent
Experimental: K-RAS native A	Drug: bevacizumab [Avastin]; 5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent; Drug: mFOLFOX6; Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent
Active Comparator: K-RAS native B	Drug: cetuximab; 400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent; Drug: mFOLFOX6; Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Overall survival [up to 4 years]

2. Objective response rate [4 years]

3. Safety: Incidence of adverse events [4 years]

4. Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30) [up to 4 years]

5. Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms [up to 4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01338558
• Other Study ID Numbers: ML25686
• First Posted: Apr 19, 2011
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Colorectal Neoplasms; Bevacizumab; Cetuximab

Study Results

No Results Posted as of Nov 2, 2016