A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: Leucovorin; Drug: 5 FU; Drug: capecitabine [Xeloda]; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00069108

NO16967

Details and patient eligibility

About

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.

Enrollment: 627 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

627 participants in 2 patient groups

XELOX

Experimental group

Description:

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).

Treatment:

Drug: Oxaliplatin

Drug: capecitabine [Xeloda]

Drug: Oxaliplatin

FOLFOX-4

Active Comparator group

Description:

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).

Treatment:

Drug: Oxaliplatin

Drug: 5 FU

Drug: Oxaliplatin

Drug: Leucovorin