Roche trials database

Trial information

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 57.

Study phase:

II

Study type:

Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Safety/efficacy study

Conditions:

• 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:

• adult patients >=18 years of age;
• locally advanced and/or metastatic colorectal cancer;
• >=1 target lesion.

Exclusion criteria:

• previous treatment with Xeloda or irinotecan;
• previous systemic therapy for metastatic disease;
• progressive disease during previous adjuvant therapy or within 6 months of completion.

Gender:

Males or Females

Age limits:

Min: 18 years Max: N/A (No limit)

Accepts healthy volunteers:

No

Anticipated start date:

July, 2001

Trial registration date:

21.12.2005

Date last updated:

22.01.2010

This trial was conducted at the following locations:

U.S.A.

• HOOVER, AL
• LA JOLLA, CA
• MIAMI, FL
• BOSTON, MA
• CHARLOTTE, NC
• ALBUQUERQUE, NM
• NEW YORK, NY
• PROVIDENCE, RI
• NASHVILLE, TN

UNITED STATES

• Memphis, TN

Link to trial result