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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Hoover, Alabama, United States, 35216
  • California
    • La Jolla, California, United States, 92037-1030
  • Florida
    • Miami, Florida, United States, 33176
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
  • New York
    • New York, New York, United States, 10028
  • North Carolina
    • Charlotte, North Carolina, United States, 28233-3549
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
  • Tennessee
    • Memphis, Tennessee, United States, 38120
    • Nashville, Tennessee, United States, 37203-1632

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; 100mg/m2 iv on days 1, 8, 15 and 22 of each 6 week cycle.; Drug: capecitabine [Xeloda]; 1000mg po bid

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Primary Completion (Actual): January 1, 2005
• Study Completion (Actual): January 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: MO16460