Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Ministry of Health, Malaysia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT00697905
First received: June 12, 2008
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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
Nasopharyngeal Carcinoma
Drug: Gemcitabine
Drug: Carboplatin
Drug: Cisplatin
Drug: 5-fluorouracil (5-FU)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 52
Study Start Date: January 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697905

Contacts
Contact: Christina Ng 603-7949-2185

Locations
Malaysia
Ipoh Specialist Centre Not yet recruiting
Ipoh, Malaysia
Johor Specialist Centre Not yet recruiting
Johor Bahru, Malaysia
Sabah Medical Centre Recruiting
Kota Kinabalu, Malaysia
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia
Tung Shin Hospital Recruiting
Kuala Lumpur, Malaysia
Hospital Universiti Sains Malaysia Recruiting
Kubang Kerian, Malaysia
Normah Medical Specialist Centre Recruiting
Kuching, Malaysia
Likas Hospital Recruiting
Likas, Malaysia
NCI Cancer Hospital Recruiting
Nilai, Malaysia
Loh Guan Lye Specialist Centre Not yet recruiting
Penang, Malaysia
Penang General Hospital Not yet recruiting
Penang, Malaysia
Sponsors and Collaborators
Ministry of Health, Malaysia
Investigators
Principal Investigator: Christina Ng University Malaya Medical Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Christina Ng Van Tze, University of Malaya Medical Centre
ClinicalTrials.gov Identifier: NCT00697905     History of Changes
Other Study ID Numbers: CT 06-01
Study First Received: June 12, 2008
Last Updated: April 22, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by Ministry of Health, Malaysia:
nasopharyngeal carcinoma
Gemcitabine-Carboplatin

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

ClinicalTrials.gov processed this record on July 22, 2014