drugset / Trial / NCT00697905
Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the study is to assess if gemcitabine in combination with carboplatin as 1st line chemotherapy in patients with metastatic or recurrent nasopharyngeal carcinoma has reasonable efficacy and a favourable toxicity profile that warrants further comparative study. A parallel group of randomly selected patients of equal number to the carboplatin and gemcitabine combination arm will be treated with the cisplatin and 5-FU combination chemotherapy (active control arm). The hypothesis is that this combination of chemotherapy is at least as active and less toxic than the reference regimen of cisplatin in combination with 5-fluorouracil (5-FU).
Timeline
- Start
- 2008-01
- Primary completion
- 2011-05
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Comparator | Cisplatin | Other / unclassified | — | Intravenous |
| Subject | Gemcitabine | Small molecule | — | Intravenous |
| Comparator | fluorouracil | Small molecule | — | Intravenous |