Status:
TERMINATED
A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first li...
Eligibility Criteria
Inclusion
- Adult patients, ≥18 years of age
- Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
- ≥1 measurable target lesion
- Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Exclusion
- Prior systemic therapy for advanced or metastatic disease
- History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
- Clinically significant cardiovascular disease
- Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
- Chronic daily treatment with \>325 mg/day aspirin
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00642603
Start Date
May 1 2008
End Date
March 1 2009
Last Update
March 29 2018
Active Locations (76)
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1
PARK Springs, Arizona, United States, 71913
2
Sedona, Arizona, United States, 86336
3
Tucson, Arizona, United States, 85712
4
Anaheim, California, United States, 92801