Trial Information
A Randomized, Open-label Study Comparing the Effect of 3 Chemotherapy Regimens Containing Avastin on Time to Disease Progression in Patients With Metastatic Colorectal Cancer
Inclusion Criteria:
- adult patients >=18 years of age;
- colon or rectal cancer, with metastases;
- >=1 measurable lesion.
Exclusion Criteria:
- previous systemic treatment for advanced disease;
- radiotherapy to any site within 4 weeks before study;
- daily aspirin (>325 mg/day), anticoagulants, or other medications known to predispose
to gastrointestinal ulceration;
- co-existing malignancies or malignancies diagnosed within last 5 years (except basal
cell cancer or cervical cancer in situ).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression\n
Outcome Time Frame:
From the first day of treatment until the first observation of disease progression, or death due to any cause (up to 5 years)
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
ITALY: Agenzia Italiana del Farmaco
Study ID:
ML18524
NCT ID:
NCT01131078
Start Date:
June 2005
Completion Date:
December 2012
Related Keywords:
- Colorectal Cancer
- Colonic Neoplasms
- Colorectal Neoplasms