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
  Purpose
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.

Condition Intervention Phase
Gastric Cancer
Drug: Cisplatin
Drug: Capecitabine
Drug: Epirubicin
Drug: Oxaliplatin
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) [ Time Frame: Approximately 3.25 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 158
Study Start Date: March 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
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.
Drug: Epirubicin
50 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
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.
Drug: Cisplatin
60 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454636

  Show 51 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00454636     History of Changes
Other Study ID Numbers: ML20777 
Study First Received: March 30, 2007
Results First Received: July 12, 2016
Last Updated: July 12, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Oxaliplatin
Cisplatin
Capecitabine
Epirubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 23, 2016