Trial Information

Summary: A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

Status: Completed

Protocol Number: MO16460

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of continuous Xeloda therapy in combination with irinotecan on treatment response in patients with advanced and/or metastatic colorectal cancer

Brief Summary: This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals. Target sample size is 50.

Study Phase: II

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Colorectal Cancer

Intervention Type: Drug

Intervention Name: capecitabine [Xeloda]

Primary Outcome: 1. Tumor measurements (RECIST criteria) Time frame: Event driven

Key Secondary Outcomes: 1. Time to progression, time to response, duration of response, time to treatment failure, survival. Time frame: Event driven

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: June 30, 2008 at 3:02:23 PM