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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: February 16, 2007
Last updated: October 3, 2016
Last verified: October 2016
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.

Condition Intervention Phase
Gastric Cancer
Drug: Oxaliplatin
Drug: capecitabine [Xeloda]
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression, overall survival, duration of response, time to response. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: March 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Oxaliplatin
85mg/m2 iv on day 1 of each 2 week cycle
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-10 of each 2 week cycle


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00436241

Chai Yi, Taiwan, 613
Chai Yi, Taiwan, 622
Kaohsiung, Taiwan, 807
Keelung, Taiwan, 204
Taichung, Taiwan, 404
Taichung, Taiwan, 407
Tainan, Taiwan, 704
Tainan, Taiwan, 710
Taipei, Taiwan, 00112
Taipei, Taiwan, 106
Taipei, Taiwan, 110
Taoyuan, Taiwan, 333
Yilan, Taiwan, 265
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00436241     History of Changes
Other Study ID Numbers: ML20734 
Study First Received: February 16, 2007
Last Updated: October 3, 2016
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on October 25, 2016