A Study of Xeloda (Capecitabine) as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer.

Gastric Cancer Clinical Trial

Official title:

A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced and/or Metastatic Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436241
• Other study ID #: ML20734
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2007
• Last updated: November 1, 2016
• Start date: March 2007
• Est. completion date: November 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease. Eligible patients will receive Xeloda 1000mg/m2 po twice daily, D1-D10 every 2 weeks (10 days treatment followed by 4 days rest period) plus oxaliplatin 85 mg/m2/day iv, D1 every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• gastric cancer with unresectable locally advanced and/or metastatic disease;

• >=1 measurable lesion;

• ambulatory, with ECOG Performance Status >=1.

Exclusion Criteria:

• previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to enrollment);

• clinically significant cardiac disease or myocardial infarction within last 12 months;

• CNS metastases;

• history of other malignancy within last 5 years, except for cured basal cell cancer of the skin, or in situ cancer of the cervix.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Oxaliplatin
85mg/m2 iv on day 1 of each 2 week cycle
• capecitabine [Xeloda]
1000mg/m2 po bid on days 1-10 of each 2 week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Event driven	No
Secondary	Time to disease progression, overall survival, duration of response, time to response.		Event driven	No
Secondary	AEs, laboratory parameters.		Throughout study	No