A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
XELOX
FOLFOX-4
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).