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: October 13, 2014
Last verified: October 2014
  Purpose

This single arm study will assess the efficacy and safety of Xeloda in combinati on with oxaliplatin as first-line chemotherapy in patients with advanced and/or metastatic gastric cancer who have had no prior chemotherapy for advanced or met astatic 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 ox aliplatin 85 mg/m2/day iv, D1 every 2 weeks. The anticipated time on study treat ment is until disease progression, and the target sample size is <100 individual s.


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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 106
Taipei, Taiwan, 110
Taipei, Taiwan, 00112
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: October 13, 2014
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
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014