Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Capecitabine (Xeloda) in Participants 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.
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

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE September 29, 2015
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE April 2003
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
Time to disease progression [ Time Frame: Up to approximately 7.3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02563054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2015)
  • Objective tumor response rate [ Time Frame: Up to approximately 7.3 years ]
  • Overall survival [ Time Frame: Up to approximately 7.3 years ]
  • Duration of response [ Time Frame: Up to approximately 7.3 years ]
  • Time to response [ Time Frame: Up to approximately 7.3 years ]
  • Incidence of adverse events [ Time Frame: Up to approximately 7.3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • 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: 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.
Study Arms  ICMJE
  • Active Comparator: 5-Fluorouracil + Cisplatin
    Participants will receive 5-FU in combination with cisplatin upto disease progression.
    Interventions:
    • Drug: 5-Fluorouracil
    • Drug: Cisplatin
  • Experimental: Capecitabine + Cisplatin
    Participants will receive capecitabine in combination with cisplatin upto disease progression.
    Interventions:
    • Drug: Capecitabine
    • Drug: Cisplatin
Publications * Chen J, Xiong J, Wang J, Zheng L, Gao Y, Guan Z. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin in Chinese patients with advanced and metastatic gastric cancer: Re-analysis of efficacy and safety data from the ML17032 phase III clinical trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e310-e316. doi: 10.1111/ajco.12832. Epub 2018 Jan 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2015)
316
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belize,   Brazil,   China,   Colombia,   Guatemala,   Hong Kong,   Korea, Republic of,   Malaysia,   Mexico,   Panama,   Peru,   Russian Federation,   Uruguay
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563054
Other Study ID Numbers  ICMJE ML17032
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP