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Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697905
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : November 21, 2014
Information provided by:
Ministry of Health, Malaysia

Brief 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).

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Gemcitabine Drug: Carboplatin Drug: Cisplatin Drug: 5-fluorouracil (5-FU) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Labeled, Multicentre, Randomized Phase II Trial of Combination Gemcitabine and Carboplatin Chemotherapy in Patients With Metastatic or Recurrent Nasopharyngeal Carcinoma
Study Start Date : January 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: A Drug: Gemcitabine
Intravenous administration on days 1, 8 of a 21-day cycle

Drug: Carboplatin
Intravenous following Gemcitabine infusion on day 1

Active Comparator: B 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

Primary Outcome Measures :
  1. The primary efficacy variable is response to therapy. Response will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Progression free survival defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first. [ Time Frame: 12 months ]
  2. Duration of response defined as the interval between the first documented response (CR or PR) and the first documented sign of disease progression or death, whichever occurs first. [ Time Frame: 12 months ]
  3. Safety and tolerability assessments will consist of 1.Monitoring and recording all AE and SAE, 2.Regular monitoring of hematology, blood chemistry and urinary laboratory parameters, 3.Regular performance of physical examinations, including vital signs [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Written informed consent obtained from patient or parents/guardian.
  2. Subject age greater than or equal to 18 years
  3. Histologically proven recurrent or metastatic undifferentiated or squamous nasopharyngeal carcinoma, not amenable to local therapy.
  4. Measurable disease in distant sites and/or loco-regional sites defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded as >=10mm with CT scan or MRI. Tumour lesions that are situated in a previously irradiated field are measurable only if the tissue planes are preserved on CT or MRI).
  5. Prior concurrent chemotherapy and radiation therapy is permitted.
  6. Primary chemo-radiotherapy must be completed at least 6 months prior to study entry.
  7. Life expectancy over 3 months.
  8. ECOG performance status less than or equal to 2.
  9. Patients must have normal organ and marrow function as follows:

    • White blood cell count : >= 3.0 x 10^9/L
    • Absolute neutrophil count : >= 1.5 x 10^9/L
    • Platelets : >= 100 x 10^9/L
    • Total bilirubin : within normal limits
    • AST/ALT/ALP : <= 2.5 x upper limit of normal
    • Creatinine clearance or estimated GFR : >=50 mls/min.

Exclusion Criteria:

Patients with any of the following are not eligible for enrollment into the study:

  1. Pregnant women are excluded from this study because gemcitabine has potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with gemcitabine, breastfeeding should be discontinued if the mother is treated with gemcitabine. These potential risks may also apply to other agents used in this study.
  2. Women of child-bearing potential and men without an adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  3. Prior use of gemcitabine
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or carboplatin.
  5. Prior lines of chemotherapy for metastatic NPC
  6. Prior radiotherapy to the indicator lesion(s) to be measured in the study.
  7. Patients receiving any other investigational agents
  8. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  9. Patients with bone-only metastases.
  10. Clinically significant cardiac disease (e.g. congestive cardiac failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
  11. Severe sensorineural hearing loss affecting normal daily activities or requiring the use of hearing aids.
  12. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  13. Patients with immune deficiency. They are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  14. HIV-positive patients receiving combination antiretroviral therapy. There is a possible pharmacokinetic interaction between antiretroviral and gemcitabine or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697905

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Ipoh Specialist Centre
Ipoh, Malaysia
Johor Specialist Centre
Johor Bahru, Malaysia
Sabah Medical Centre
Kota Kinabalu, Malaysia
Tung Shin Hospital
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Universiti Sains Malaysia
Kubang Kerian, Malaysia
Normah Medical Specialist Centre
Kuching, Malaysia
Likas Hospital
Likas, Malaysia
NCI Cancer Hospital
Nilai, Malaysia
Loh Guan Lye Specialist Centre
Penang, Malaysia
Penang General Hospital
Penang, Malaysia
Sponsors and Collaborators
Ministry of Health, Malaysia
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Principal Investigator: Christina Ng University of Malaya

Additional Information:
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Responsible Party: Dr. Christina Ng Van Tze, University of Malaya Medical Centre Identifier: NCT00697905     History of Changes
Other Study ID Numbers: CT 06-01
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: April 2010

Keywords provided by Ministry of Health, Malaysia:
nasopharyngeal carcinoma

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs