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Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
An Open Labeled, Multicentre, Randomized Phase II Trial of Combination Gemcitabine and Carboplatin Chemotherapy in Patients With Metastatic or Recurrent Nasopharyngeal Carcinoma

Clinical Trial 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).

Clinical Trial Description

52 patients with metastatic or recurrent nasopharyngeal carcinoma who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then be randomly allocated to carboplatin and gemcitabine or cisplatin and 5-FU combinations in a ratio of 1:1. Study visits will occur depending on which arm the patient is on.

An economic evaluation of the costs and benefits of gemcitabine-carboplatin will be implemented within this protocol. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00697905
Study type Interventional
Source Ministry of Health, Malaysia
Contact
Status Completed
Phase Phase 2
Start date January 2008
Completion date May 2011
View Details
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