A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Oxaliplatin; Drug: bevacizumab; Drug: capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00118755

ML18491

Details and patient eligibility

About

This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Enrollment: 435 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metastatic or inoperable locally advanced colorectal cancer
• >=1 measurable target lesion

Exclusion criteria

• Previous systemic therapy for advanced or metastatic disease
• Previous treatment with bevacizumab

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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435 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: bevacizumab

Drug: Oxaliplatin

Drug: capecitabine

Drug: capecitabine

Drug: bevacizumab

Drug: Oxaliplatin

2

Active Comparator group

Treatment:

Drug: bevacizumab

Drug: Oxaliplatin

Drug: capecitabine

Drug: capecitabine

Drug: bevacizumab

Drug: Oxaliplatin