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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00454636
First received: March 30, 2007
Last updated: July 12, 2016
Last verified: July 2016

March 30, 2007
July 12, 2016
March 2007
July 2010   (final data collection date for primary outcome measure)
Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) [ Time Frame: Approximately 3.25 years ] [ Designated as safety issue: No ]
Assessment of safety profile, specifically the incidence of hand-foot syndrome.
Complete list of historical versions of study NCT00454636 on ClinicalTrials.gov Archive Site
  • Overall Response Rate (ORR) [ Time Frame: Approximately 3.25 years ] [ Designated as safety issue: No ]
    ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR).
  • Progression-Free Survival (PFS) [ Time Frame: Approximately 3.25 years ] [ Designated as safety issue: No ]
    PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause.
  • Overall Survival (OS) [ Time Frame: Approximately 3.25 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Duration of Response was defined as the time of CR or PR until the first date of recurrent or progressive disease.
  • Time to Response [ Time Frame: Approximately 3.25 years ] [ Designated as safety issue: No ]
    Time to Response was defined as the date of start of treatment until the first date of CR or PR.
Time to response, duration of response, overall response rate, survival time.
Not Provided
Not Provided
 
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00454636
ML20777
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2016

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