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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00454636
First received: March 30, 2007
Last updated: September 22, 2014
Last verified: September 2014

March 30, 2007
September 22, 2014
February 2007
May 2009   (final data collection date for primary outcome measure)
Safety profile, specifically incidence of hand-foot syndrome [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Assessment of safety profile, specifically the incidence of hand-foot syndrome.
Complete list of historical versions of study NCT00454636 on ClinicalTrials.gov Archive Site
Time to response, duration of response, overall response rate, survival time. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Time to response, duration of response, overall response rate, survival time.
Not Provided
Not Provided
 
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
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.

This single arm study will assess the safety and efficacy of Xeloda, given in co mbination with standard chemotherapy regimens, for the first-line treatment of a dvanced and/or metastatic gastric cancer. All patients will receive Xeloda in co mbination 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 u sed. The anticipated time on study treatment is until disease progression, and t he target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: Standard chemotherapy
    As prescribed
  • Drug: capecitabine [Xeloda]
    625mg/m2 po bid increasing to 1000mg/m2 po bid
Experimental: 1
Interventions:
  • Drug: Standard chemotherapy
  • Drug: capecitabine [Xeloda]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00454636
ML20777
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP