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

Roche

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Oxaliplatin; Drug: Cisplatin; Drug: Docetaxel; Drug: Epirubicin; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454636

ML20777

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 4 patient groups

Cisplatin / Capecitabine

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Cisplatin

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

Epirubicin / Cisplatin / Capecitabine

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Cisplatin

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

Drug: Epirubicin

Epirubicin / Oxaliplatin / Capecitabine

Experimental group

Description:

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.

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine

Drug: Epirubicin

Docetaxel / Cisplatin / Capecitabine

Experimental group

Description:

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.

Treatment:

Drug: Cisplatin

Drug: Cisplatin

Drug: Docetaxel

Drug: Capecitabine

Drug: Capecitabine

Drug: Capecitabine