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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00454636
First Posted: April 2, 2007
Last Update Posted: September 29, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: March 30, 2007
First Posted: April 2, 2007
Results First Submitted: July 12, 2016
Results First Posted: August 19, 2016
Last Update Posted: September 29, 2016
Last Verified: August 2016

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


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