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
Primary Purpose
Colorectal Cancer
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
bevacizumab [Avastin]
cetuximab
mFOLFOX6
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
K-RAS mutated
K-RAS native A
K-RAS native B
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria
Secondary Outcome Measures
Overall survival
Objective response rate
Safety: Incidence of adverse events
Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)
Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01338558
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Study Start Date
June 2011 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
K-RAS mutated
Arm Type
Experimental
Arm Title
K-RAS native A
Arm Type
Experimental
Arm Title
K-RAS native B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent
Intervention Type
Drug
Intervention Name(s)
mFOLFOX6
Intervention Description
Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent
Primary Outcome Measure Information:
Title
Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria
Time Frame
up to 4 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
up to 4 years
Title
Objective response rate
Time Frame
4 years
Title
Safety: Incidence of adverse events
Time Frame
4 years
Title
Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)
Time Frame
up to 4 years
Title
Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms
Time Frame
up to 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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