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

Phase 2
18 Years
Open (Enrolling)
Nasopharyngeal Carcinoma

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Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Christina Ng

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Malaya Medical Centre


Malaysia: Ministry of Health

Study ID:

CT 06-01



Start Date:

January 2008

Completion Date:

December 2011

Related Keywords:

  • Nasopharyngeal Carcinoma
  • nasopharyngeal carcinoma
  • Gemcitabine-Carboplatin
  • Carcinoma
  • Nasopharyngeal Neoplasms