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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436241
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Oxaliplatin Drug: capecitabine [Xeloda] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Event driven ]

Secondary Outcome Measures :
  1. Time to disease progression, overall survival, duration of response, time to response. [ Time Frame: Event driven ]
  2. AEs, laboratory parameters. [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436241

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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
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT00436241     History of Changes
Other Study ID Numbers: ML20734
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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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