A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.
Phase 2
Completed
- Conditions
- Nasopharyngeal Cancer
- Interventions
- Registration Number
- NCT00439426
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm study will assess the efficacy and safety of Xeloda + oxaliplatin when given as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7 days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- adult patients, 18-75 years of age;
- history of nasopharyngeal cancer and distant metastases;
- no previous chemotherapy in past 6 months;
- recovery from previous radiotherapy;
- ability to swallow and retain oral medication.
Exclusion Criteria
- previous cytotoxic chemotherapy;
- radiotherapy within 4 weeks of treatment start;
- history of another malignancy within the last 5 years;
- clinically significant cardiac disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 capecitabine [Xeloda] - 1 Oxaliplatin -
- Primary Outcome Measures
Name Time Method Overall response rate Event driven
- Secondary Outcome Measures
Name Time Method AEs, laboratory parameters. Throughout study Time to disease progression or death, survival time, duration of response, complete response rate. Event driven