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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00436241
First received: February 16, 2007
Last updated: June 18, 2013
Last verified: June 2013
History of Changes
  Purpose

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: capecitabine [Xeloda]
Drug: Oxaliplatin
 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:

U.S. FDA Resources

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

  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;
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436241

Locations
Taiwan
Chai Yi, Taiwan, 613
Chai Yi, Taiwan, 622
Kaohsiung, Taiwan, 807
Keelung, Taiwan, 204
Taichung, Taiwan, 407
Taichung, Taiwan, 404
Tainan, Taiwan, 704
Tainan, Taiwan, 710
Taipei, Taiwan, 110
Taipei, Taiwan, 00112
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Yilan, Taiwan, 265
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00436241     History of Changes
Other Study ID Numbers: ML20734
Study First Received: February 16, 2007
Last Updated: June 18, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013