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Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma

NCT00697905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2014-11-21

No results posted yet for this study

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).

Conditions

  • Nasopharyngeal Carcinoma

Interventions

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

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Christina Ng · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00697905 on ClinicalTrials.gov