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Sponsored by: |
Ministry of Health, Malaysia |
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Information provided by: | Ministry of Health, Malaysia |
ClinicalTrials.gov Identifier: | NCT00697905 |
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).
Condition | Intervention | Phase |
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Nasopharyngeal Carcinoma |
Drug: Gemcitabine Drug: Carboplatin Drug: Cisplatin Drug: 5-fluorouracil (5-FU) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Labeled, Multicentre, Randomized Phase II Trial of Combination Gemcitabine and Carboplatin Chemotherapy in Patients With Metastatic or Recurrent Nasopharyngeal Carcinoma |
Estimated Enrollment: | 52 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Gemcitabine
Intravenous administration on days 1, 8 of a 21-day cycle
Drug: Carboplatin
Intravenous following Gemcitabine infusion on day 1
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B: Active Comparator |
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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ and marrow function as follows:
Exclusion Criteria:
Patients with any of the following are not eligible for enrollment into the study:
Contact: Christina Ng | 37-949-2185 |
Malaysia | |
Penang General Hospital | Not yet recruiting |
Penang, Malaysia | |
Likas Hospital | Not yet recruiting |
Likas, Malaysia | |
Sabah Medical Centre | Not yet recruiting |
Kota Kinabalu, Malaysia | |
University Malaya Medical Centre | Recruiting |
Kuala Lumpur, Malaysia | |
Tung Shin Hospital | Not yet recruiting |
Kuala Lumpur, Malaysia | |
Nilai Cancer Hospital | Not yet recruiting |
Nilai, Malaysia |
Principal Investigator: | Christina Ng | University Malaya Medical Centre |
Responsible Party: | University of Malaya Medical Centre ( Dr. Christina Ng Van Tze ) |
Study ID Numbers: | CT 06-01 |
Study First Received: | June 12, 2008 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00697905 |
Health Authority: | Malaysia: Ministry of Health |
nasopharyngeal carcinoma Gemcitabine-Carboplatin |
Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Pharyngeal Neoplasms Carboplatin Pharyngeal Diseases Recurrence Nasopharyngeal Neoplasms Carcinoma |
Nasopharyngeal carcinoma Cisplatin Head and Neck Neoplasms Fluorouracil Stomatognathic Diseases Gemcitabine Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Nasopharyngeal Diseases |