A Randomized, Open Label Study to Assess the Effect on Progression-free Survival and Disease Response of Avastin + Xeloda as Maintenance Treatment, After Initial Combination Treatment With Xeloda + Oxaliplatin + Avastin in Patients With Metastatic Colorectal Adenocarcinoma
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Randomized, Open Label Study to Assess the Effect on Progression-free Survival and Disease Response of Avastin + Xeloda as Maintenance Treatment, After Initial Combination Treatment With Xeloda + Oxaliplatin + Avastin in Patients With Metastatic Colorectal Adenocarcinoma
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically confirmed colon or rectal cancer, with unresectable metastatic
disease;
- at least one measurable lesion;
- outpatient, with ECOG Performance Status 0-1.
Exclusion Criteria:
- previous treatment with Avastin;
- previous systemic treatment for advanced or metastatic disease;
- clinically significant cardiovascular disease;
- daily chronic treatment with high doses of aspirin (>325mg/day) or NSAIDs.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Turkey: Ministry of Health
Study ID:
ML21440
NCT ID:
NCT00623805
Start Date:
March 2008
Completion Date:
June 2011
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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