Trial information
A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.
Status: Recruiting
Protocol number: ML20508
Sponsor: Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: An open label study of first line chemotherapy with Xeloda in combination with cisplatin on treatment response in patients with metastatic nasopharyngeal cancer
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. Target sample size is
42.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Nasopharyngeal Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. Overall response rate Time frame: Event driven
Key secondary outcomes: 1. Time to disease progression or death, survival time, duration of response, complete response rate. Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: March, 2007
Trial registration date: 02/16/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Morocco
- Casablanca
- Marrakech
- Rabat
