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A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02563054
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: 5-Fluorouracil Drug: Capecitabine Drug: Cisplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With Advanced and/or Metastatic Gastric Cancer
Study Start Date : April 2003
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 5-Fluorouracil + Cisplatin
Participants will receive 5-FU in combination with cisplatin upto disease progression.
 Drug: 5-Fluorouracil
Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.

Drug: Cisplatin
Participants will receive cisplastin, 80 mg/m^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.
Experimental: Capecitabine + Cisplatin
Participants will receive capecitabine in combination with cisplatin upto disease progression.
 Drug: Capecitabine
Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.

Drug: Cisplatin
Participants will receive cisplastin, 80 mg/m^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.


Outcome Measures
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Primary Outcome Measures :
  1. Time to disease progression [ Time Frame: Up to approximately 7.3 years ]

Secondary Outcome Measures :
  1. Objective tumor response rate [ Time Frame: Up to approximately 7.3 years ]
  2. Overall survival [ Time Frame: Up to approximately 7.3 years ]
  3. Duration of response [ Time Frame: Up to approximately 7.3 years ]
  4. Time to response [ Time Frame: Up to approximately 7.3 years ]
  5. Incidence of adverse events [ Time Frame: Up to approximately 7.3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 to 75 years of age
  • Advanced and/or metastatic gastric cancer with at least 1 measurable lesion

Exclusion Criteria:

  • Uncontrolled infection
  • Evidence of central nervous system (CNS) metastases
  • History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix
  • Radiation therapy or major surgery within 4 weeks of study drug
  • Previous chemotherapy
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02563054


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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02563054     History of Changes
Other Study ID Numbers: ML17032
First Posted: September 29, 2015    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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
 Capecitabine
Fluorouracil
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs