Trial Information

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

Status: Recruiting

Protocol Number: ML21567

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open label study of the effect of first line treatment with Xeloda in combination with Avastin and either short course irinotecan or short course oxaliplatin on progression-free survival in patients with metastatic colorectal cancer

Brief Summary: This 2 arm study will 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 will be randomized to receive 2-weekly cycles of treatment with either 1)Xeloda (1000mg/m2 po bid on days 1-7), Avastin (5mg/kg iv on day 1) and oxaliplatin (85mg/m2 on day 1, only in cycles 1-12) or 2)Xeloda (1000mg/m2 po bid on days 1-7), Avastin (5mg/kg iv on day 1) and irinotecan (135mg/m2 on day 1, only in cycles 1-12). After 9 cycles, patients will continue to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 230.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Colorectal Cancer

Intervention Type: Drug

Intervention Name: capecitabine [Xeloda]

Primary Outcome: 1. Progression-free survival Time frame: Event driven

Key Secondary Outcomes: 1. Overall response rate, overall survival, time to response, duration of overall response, time to progression, time to treatment failure, rate of completion of 12 cycles of triple-drug therapy, rate of surgical intervention. Time frame: Event driven 2. Progression-free survival rates Time frame: 6, 9 and 12 months 3. Adverse events, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: May, 2008

Trial Registration Date: 03/18/2008

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: June 30, 2008 at 5:00:27 PM