A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: Oxaliplatin; Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin (LV); Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00069121

NO16968

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. 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)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

Enrollment: 1,886 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)
• Complete tumor resection; Patients operated with curative intent and with no macroscopic or microscopic evidence for remaining tumor who can be randomized to either treatment arm within 8 weeks after surgery. As this is an adjuvant trial patients should never have had any evidence of metastatic disease (including presence of tumor cells in the ascites).
• Have a life expectancy of at least 5 years

Exclusion criteria

• Pregnant or lactating women
• Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
• Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated colon cancer
• Patients who have not completely recovered from surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,886 participants in 2 patient groups

5-Fluorouracil/Leucovorin (5-FU/LV)

Active Comparator group

Description:

Participants were given one of two regimens (each participating center prespecified which regimen they would use for all patients at that center): i) Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; ii) Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks).

Treatment:

Drug: Leucovorin (LV)

Drug: 5-Fluorouracil (5-FU)

Capecitabine in Combination with Oxaliplatin (XELOX)

Experimental group

Description:

Capecitabine was administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks).

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine