A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.

This study is ongoing, but not recruiting participants.

First Received: March 30, 2007 Last Updated: August 26, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00454636

Purpose

This single arm study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Gastric Cancer	Drug: capecitabine [Xeloda] Drug: Standard chemotherapy	Phase II

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 First Line Treatment With Xeloda in Combination With Chemotherapy on Safety and Treatment Response in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-based Regimen.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Safety profile, specifically incidence of hand-foot syndrome [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	157
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 625mg/m2 po bid increasing to 1000mg/m2 po bid Drug: Standard chemotherapy As prescribed

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;
advanced or metastatic gastric cancer;
ECOG <=2.

Exclusion Criteria:

previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to study);
evidence of CNS metastasis;
history of another malignancy within the last 5 years (except for successfully treated basal cell cancer of skin, or in situ cancer of the cervix);
clinically significant cardiac disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454636

Show 53 Study Locations

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:	ML20777
Study First Received:	March 30, 2007
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00454636 History of Changes
Health Authority:	Spain: Comite Etico de Investigacion Clinica

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Stomach Neoplasms
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009