A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2003 |
| End Date: | August 2006 |
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy
This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv
fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients
previously treated for metastatic colorectal cancer. Patients will be randomized to receive
either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)
FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study
treatment is until disease progression, and the target sample size is 500+ individuals.
fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients
previously treated for metastatic colorectal cancer. Patients will be randomized to receive
either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)
FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study
treatment is until disease progression, and the target sample size is 500+ individuals.
Inclusion Criteria:
- adult patients >=18 years of age;
- metastatic colorectal cancer;
- >=1 target lesion;
- failed first-line chemotherapy with 5-fluorouracil and irinotecan.
Exclusion Criteria:
- previous treatment with oxaliplatin;
- progressive or recurrent disease during or within 6 months of completion of
first-line chemotherapy;
- >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic
disease.
We found this trial at
9
sites
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