Combination of Gemcitabine and Carboplatin in Metastatic or Recurrent Nasopharyngeal Carcinoma

NCT00697905 | Completed Phase 2

• 1 other identifier: CT 06-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 11

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).

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma; Gemcitabine-Carboplatin

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (3)

• Progression free survival defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.

  12 months

• 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.

  12 months

• 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

  12 months

Study Arms (2)

A

EXPERIMENTAL

Drug: Gemcitabine; Drug: Carboplatin

B

ACTIVE COMPARATOR

Drug: Cisplatin; Drug: 5-fluorouracil (5-FU)

Interventions

Gemcitabine DRUG

Intravenous administration on days 1, 8 of a 21-day cycle

A

Carboplatin DRUG

Intravenous following Gemcitabine infusion on day 1

A

Cisplatin DRUG

Intravenous on day 1 prior to 5-FU infusion on days 2 to 5 of a 28-day cycle

B

5-fluorouracil (5-FU) DRUG

Intravenous infusion on day 2 to day 5

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained from patient or parents/guardian.
• Subject age greater than or equal to 18 years
• Histologically proven recurrent or metastatic undifferentiated or squamous nasopharyngeal carcinoma, not amenable to local therapy.
• 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).
• Prior concurrent chemotherapy and radiation therapy is permitted.
• Primary chemo-radiotherapy must be completed at least 6 months prior to study entry.
• Life expectancy over 3 months.
• ECOG performance status less than or equal to 2.
• 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.

You may not qualify if:

• Patients with any of the following are not eligible for enrollment into the study:
• 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.
• 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.
• Prior use of gemcitabine
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or carboplatin.
• Prior lines of chemotherapy for metastatic NPC
• Prior radiotherapy to the indicator lesion(s) to be measured in the study.
• Patients receiving any other investigational agents
• 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.
• Patients with bone-only metastases.
• 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.
• Severe sensorineural hearing loss affecting normal daily activities or requiring the use of hearing aids.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with immune deficiency. They are at increased risk of lethal infections when treated with marrow-suppressive therapy.
• 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.

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead

Study Sites (11)

Loh Guan Lye Specialist Centre

George Town, Malaysia

Location

Penang General Hospital

George Town, Malaysia

Location

Ipoh Specialist Centre

Ipoh, Malaysia

Location

Johor Specialist Centre

Johor Bahru, Malaysia

Location

NCI Cancer Hospital

Kampung Baharu Nilai, Malaysia

Location

Likas Hospital

Kampung Likas, Malaysia

Location

Sabah Medical Centre

Kota Kinabalu, Malaysia

Location

Tung Shin Hospital

Kuala Lumpur, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Hospital Universiti Sains Malaysia

Kubang Kerian, Malaysia

Location

Normah Medical Specialist Centre

Kuching, Malaysia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Gemcitabine; Carboplatin; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones

Study Officials

• Christina Ng

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 16, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 21, 2014

Record last verified: 2010-04

Locations

MY (11)