At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Metastatic colorectal cancer
- ✓At least one target lesion
- ✓Failed first-line chemotherapy with 5-fluorouracil and irinotecan
- ✕Prior treatment with oxaliplatin
- ✕Progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy
- ✕More than one previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating 5 FU, Leucovorin, and 2 other interventions for Colorectal Cancer. Completed, enrolled 627 participants across 87 sites in 20 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
As prescribed, in 2 week cycles
As prescribed, in 2 week cycles
As prescribed, in 3 week cycles
As prescribed, in 2 week cycles
1000mg/m2 po bid on days 1-15 of each 3 week cycle