drugset / Trial / NCT00697905

Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma

NCT00697905 ↗

Phase 2 Completed 18 enrolled Ministry of Health, Malaysia
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

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Intravenous
Comparator Cisplatin Other / unclassified — Intravenous
Subject Gemcitabine Small molecule — Intravenous
Comparator fluorouracil Small molecule — Intravenous