Trial Information

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

Status: Completed

Protocol Number: MO16461

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of intermittent Xeloda 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 intermittent oral Xeloda administration in combination with 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 measurement (RECIST criteria) Time frame: Event driven

Key Secondary Outcomes: 1. Efficacy: 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: 07/15/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: July 21, 2008 at 2:20:56 PM