NCT00697905

Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ministry of Health, Malaysia · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Intravenous administration on days 1, 8 of a 21-day cycle
DRUG	Carboplatin	Intravenous following Gemcitabine infusion on day 1
DRUG	Cisplatin	Intravenous on day 1 prior to 5-FU infusion on days 2 to 5 of a 28-day cycle
DRUG	5-fluorouracil (5-FU)	Intravenous infusion on day 2 to day 5

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2008-06-16
• Last updated: 2014-11-21

Locations

11 sites across 1 country: Malaysia