A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: Leucovorin; Drug: 5-Fluorouracil; Drug: Capecitabine [Xeloda]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00009737

M66001

Details and patient eligibility

About

This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Enrollment: 1,987 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients 18-75 years of age;
• histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.

Exclusion criteria

• previous chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,987 participants in 2 patient groups

Capecitabine

Experimental group

Description:

Participants received capecitabine 1250 milligram per square meter (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).

Treatment:

Drug: Capecitabine [Xeloda]

5-Fluorouracil + Leucovorin

Active Comparator group

Description:

Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).

Treatment:

Drug: Leucovorin

Drug: 5-Fluorouracil