An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)
Phase 2
18 Years
70 Years
18 Years
70 Years
Open (Enrolling)
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)
Inclusion Criteria:
- adult patients, 18-70 years of age;
- metastatic colorectal cancer scheduled for standard first line chemotherapy;
- at least 1 measurable lesion;
- ECOG performance score of 0 or 1.
Exclusion Criteria:
- prior chemotherapy for metastatic colorectal cancer;
- prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy
completed within 6 months prior to study entry;
- concomitant malignancies other CRC;
- history or evidence of CNS disease unrelated to cancer.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
assessed every 8 weeks up to week 102, 3-monthly during follow-up
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Germany: Paul-Ehrlich-Institut
Study ID:
ML20514
NCT ID:
NCT00940303
Start Date:
June 2009
Completion Date:
July 2013
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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