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A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.

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ClinicalTrials.gov Identifier: NCT00454636
Recruitment Status : Completed
First Posted : April 2, 2007
Results First Posted : August 19, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 30, 2007
First Posted Date  ICMJE April 2, 2007
Results First Submitted Date  ICMJE July 12, 2016
Results First Posted Date  ICMJE August 19, 2016
Last Update Posted Date September 29, 2016
Study Start Date  ICMJE March 2007
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2016)
Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) [ Time Frame: Approximately 3.25 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2007)
Assessment of safety profile, specifically the incidence of hand-foot syndrome.
Change History Complete list of historical versions of study NCT00454636 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
  • Overall Response Rate (ORR) [ Time Frame: Approximately 3.25 years ]
    ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.
  • Progression-Free Survival (PFS) [ Time Frame: Approximately 3.25 years ]
    PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
  • Overall Survival (OS) [ Time Frame: Approximately 3.25 years ]
    OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.
  • Duration of Response [ Time Frame: Approximately 3.25 years ]
    Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
  • Time to Response [ Time Frame: Approximately 3.25 years ]
    Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2007)
Time to response, duration of response, overall response rate, survival time.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
Official Title  ICMJE Open Label, Phase II Study of Capecitabine (Xeloda®) as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen
Brief Summary This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Drug: Cisplatin
    80 mg/m2/day, intravenous (IV), every 3 weeks
  • Drug: Capecitabine
    1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
    Other Name: Xeloda
  • Drug: Epirubicin
    50 mg/m2/day, IV, every 3 weeks
  • Drug: Cisplatin
    60 mg/m2/day, IV, every 3 weeks
  • Drug: Capecitabine
    625 mg/m2, oral, twice daily per 3-week cycle
    Other Name: Xeloda
  • Drug: Oxaliplatin
    130 mg/m2/day, IV, every 3 weeks
  • Drug: Docetaxel
    60 mg/m2/day, IV, every 3 weeks
  • Drug: Capecitabine
    825 mg/m2, oral, twice daily for 2 weeks
    Other Name: Xeloda
Study Arms  ICMJE
  • Experimental: Cisplatin / Capecitabine
    Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
    Interventions:
    • Drug: Cisplatin
    • Drug: Capecitabine
  • Experimental: Epirubicin / Cisplatin / Capecitabine
    Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
    Interventions:
    • Drug: Epirubicin
    • Drug: Cisplatin
    • Drug: Capecitabine
  • Experimental: Epirubicin / Oxaliplatin / Capecitabine
    Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
    Interventions:
    • Drug: Epirubicin
    • Drug: Capecitabine
    • Drug: Oxaliplatin
  • Experimental: Docetaxel / Cisplatin / Capecitabine
    Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
    Interventions:
    • Drug: Cisplatin
    • Drug: Docetaxel
    • Drug: Capecitabine
Publications * Not Provided

*   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: July 12, 2016)
158
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • advanced or metastatic gastric cancer;
  • Eastern Cooperative Oncology Group (ECOG) <=2.

Exclusion Criteria:

  • previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to study);
  • evidence of central nervous system (CNS) metastasis;
  • history of another malignancy within the last 5 years (except for successfully treated basal cell cancer of skin, or in situ cancer of the cervix);
  • clinically significant cardiac disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00454636
Other Study ID Numbers  ICMJE ML20777
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 Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2016

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