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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Capecitabine
* Drug: Epirubicin
* Drug: Cisplatin
* Drug: Capecitabine
* Drug: Oxaliplatin
* Drug: Docetaxel
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisplatin / Capecitabine<br>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<br>* 80 mg/m2/day, intravenous (IV), every 3 weeks<br>Drug: Capecitabine<br>* 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle<br>* Other names: Xeloda;|
| Experimental: Epirubicin / Cisplatin / Capecitabine<br>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<br>* 50 mg/m2/day, IV, every 3 weeks<br>Drug: Cisplatin<br>* 60 mg/m2/day, IV, every 3 weeks<br>Drug: Capecitabine<br>* 625 mg/m2, oral, twice daily per 3-week cycle<br>* Other names: Xeloda;|
| Experimental: Epirubicin / Oxaliplatin / Capecitabine<br>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<br>* 50 mg/m2/day, IV, every 3 weeks<br>Drug: Capecitabine<br>* 625 mg/m2, oral, twice daily per 3-week cycle<br>* Other names: Xeloda;Drug: Oxaliplatin<br>* 130 mg/m2/day, IV, every 3 weeks<br>|
| Experimental: Docetaxel / Cisplatin / Capecitabine<br>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<br>* 60 mg/m2/day, IV, every 3 weeks<br>Drug: Docetaxel<br>* 60 mg/m2/day, IV, every 3 weeks<br>Drug: Capecitabine<br>* 825 mg/m2, oral, twice daily for 2 weeks<br>* Other names: Xeloda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) |  | Approximately 3.25 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | 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. | Approximately 3.25 years | 
| Progression-Free Survival (PFS) | 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. | Approximately 3.25 years | 
| Overall Survival (OS) | OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up. | Approximately 3.25 years | 
| Duration of Response | 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. | Approximately 3.25 years | 
| Time to Response | 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. | Approximately 3.25 years |