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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Irinotecan; Drug: capecitabine [Xeloda]

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
  • California
    • Fountain Valley, California, United States, 92708
    • La Jolla, California, United States, 92037-1030
    • Santa Rosa, California, United States, 95403
  • Colorado
    • Denver, Colorado, United States, 80262
  • Kansas
    • Hutchinson, Kansas, United States, 67502
  • Nevada
    • Las Vegas, Nevada, United States, 89109
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
    • Albuquerque, New Mexico, United States, 87131-5636
  • New York
    • Buffalo, New York, United States, 14263
  • Texas
    • Houston, Texas, United States, 77030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Irinotecan; 250mg/m2 iv on day 1 of each 3 week cycle; Drug: capecitabine [Xeloda]; 1000mg/m2 po bid on days 1-15 of each 3 week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor measurement (RECIST criteria)	Event driven

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy: Time to progression, time to response, duration of response, time to treatment failure, survival.	Event driven

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: October 24, 2002
• First Submitted That Met QC Criteria: October 24, 2002
• First Posted (Estimate): October 25, 2002

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Capecitabine; Irinotecan
• Other Study ID Numbers: MO16461

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No