A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.

Roche

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Cancer

Treatments: Drug: capecitabine [Xeloda]; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00439426

ML20508

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Oxaliplatin

Drug: capecitabine [Xeloda]