A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

Roche

Status and phase: Terminated; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: capecitabine [Xeloda]; Drug: bevacizumab [Avastin]; Drug: oxaliplatin; Drug: irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642603

ML21567

Details and patient eligibility

About

This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, ≥18 years of age
• Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
• ≥1 measurable target lesion
• Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Exclusion criteria

• Prior systemic therapy for advanced or metastatic disease
• History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
• Clinically significant cardiovascular disease
• Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
• Chronic daily treatment with >325 mg/day aspirin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

XELOX + bevacizumab (Q2W)

Experimental group

Treatment:

Drug: oxaliplatin

Drug: capecitabine [Xeloda]

Drug: bevacizumab [Avastin]

Drug: capecitabine [Xeloda]

XELIRI + bevacizumab (Q2W)

Experimental group

Treatment:

Drug: irinotecan

Drug: capecitabine [Xeloda]

Drug: bevacizumab [Avastin]

Drug: capecitabine [Xeloda]