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

This study has been completed.

First Received: October 24, 2002 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048126

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine [Xeloda] Drug: Irinotecan	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Tumor measurements (RECIST criteria) [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to progression, time to response, duration of response, time to treatment failure, survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment:	57
Study Completion Date:	January 2005

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048126

Locations

United States, Alabama

HOOVER, Alabama, United States, 35216
United States, California

LA JOLLA, California, United States, 92037-1030
United States, Florida

MIAMI, Florida, United States, 33176
United States, Massachusetts

BOSTON, Massachusetts, United States, 02120
United States, New Mexico

ALBUQUERQUE, New Mexico, United States, 87102
United States, New York

NEW YORK, New York, United States, 10028
United States, North Carolina

CHARLOTTE, North Carolina, United States, 28233-3549
United States, Rhode Island

PROVIDENCE, Rhode Island, United States, 02908
United States, Tennessee

NASHVILLE, Tennessee, United States, 37203-1632

MEMPHIS, Tennessee, United States, 38120

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MO16460
Study First Received:	October 24, 2002
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00048126 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Enzyme Inhibitors
Intestinal Diseases

Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009