Trial Information
An Open Label Study to Assess the Resection Rate of Liver Metastases Following Neoadjuvant Therapy With Avastin in Combination With Oxaliplatin and Capecitabine (XELOX) in Patients With Metastatic Colorectal Cancer With Unresectable Liver Metastasis
Inclusion Criteria:
- adult patients, <=75 years of age;
- chemotherapy-naive for stage IV colorectal cancer with unresectable liver metastasis;
- >=1 measurable lesion;
- ECOG status 0-2.
Exclusion Criteria:
- prior exposure to Avastin;
- clinical or radiological evidence of CNS metastases;
- uncontrolled hypertension, or clinically significant cardiovascular disease;
- ongoing treatment with aspirin (>325mg/day) or other medications known to predispose
to gastrointestinal ulceration.
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:
Resection of liver metastasis after neoadjuvant treatment
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Taiwan: Department of Health
Study ID:
ML21209
NCT ID:
NCT00700570
Start Date:
August 2008
Completion Date:
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms