A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2008 |
| End Date: | March 2009 |
A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer
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 line treatment in patients with metastatic colorectal cancer. Patients were
randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and
oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to
receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment
was until disease progression, and the target sample size was 100-500 individuals.
Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12
cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were
randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and
oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to
receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment
was until disease progression, and the target sample size was 100-500 individuals.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
71
sites
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