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

Gastric Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454636
• Other study ID #: ML20777
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2007
• Last updated: March 1, 2016
• Start date: February 2007
• Est. completion date: May 2009

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comite Etico de Investigacion Clinica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Standard chemotherapy
As prescribed
• capecitabine [Xeloda]
625mg/m2 po bid increasing to 1000mg/m2 po bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile, specifically incidence of hand-foot syndrome		Throughout study	No
Secondary	Time to response, duration of response, overall response rate, survival time.		Event driven	No