Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Gemcitabine and Cisplatin/Carboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer

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.
ClinicalTrials.gov Identifier: NCT00603915
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : August 10, 2011
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Health Network, Toronto

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Nasopharyngeal Cancer
Interventions Drug: Gemcitabine
Drug: Carboplatin/Cisplatin
Drug: erlotinib
Enrollment 20
Recruitment Details Study was activated on 14-June-2006. Patients with nasopharyngeal carcinoma meeting the eligibility criteria specified in the protocol were enrolled.
Pre-assignment Details  
Arm/Group Title GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB
Hide Arm/Group Description patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB
Hide Arm/Group Description patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  80.0%
>=65 years
4
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
7
  35.0%
Male
13
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 20 participants
20
Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
0 10
1 10
[1]
Measure Description:

ECOG Performance Status is a scale and criteria to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. A lower ECOG indicates a better outcome.

0 - fully active

  1. - restricted in physically strenuous activity
  2. - able to do selfcare, but unable to carry out any work activities
  3. - capable of only limited selfcare
  4. - completely disabled
  5. - dead
1.Primary Outcome
Title Progression Free Survival.
Hide Description From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died.
Time Frame From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB
Hide Arm/Group Description:
patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Overall Number of Participants Analyzed 19
Mean (95% Confidence Interval)
Unit of Measure: Months
6.3
(5.0 to 8.6)
2.Secondary Outcome
Title Number of Participants With the Responses Outlined
Hide Description

Complete Response (CR): disappearance of all clinical and radiological evidence of tumour.

Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions will also constitute progressive disease.

Time Frame Measured every 2 cycles until the participant is off treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB
Hide Arm/Group Description:
patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
Complete Response 0
Partial Response 7
Stable Disease 11
Progressive Disease 1
Inevaluable 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB
Hide Arm/Group Description patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
All-Cause Mortality
GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB
Affected / at Risk (%) # Events
Total   7/20 (35.00%)    
Blood and lymphatic system disorders   
Platelets   1/20 (5.00%)  1
General disorders   
Pyrexia   1/20 (5.00%)  1
Dehydration   1/20 (5.00%)  1
Infections and infestations   
Pneumonia   2/20 (10.00%)  2
Nervous system disorders   
Syncope   2/20 (10.00%)  3
Stroke   1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism   2/20 (10.00%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB
Affected / at Risk (%) # Events
Total   20/20 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased   19/20 (95.00%)  19
Lymphocyte Count decreased   19/20 (95.00%)  19
Leukocyte count decreased   18/20 (90.00%)  19
Neutrophil count decreased   18/20 (90.00%)  18
General disorders   
Fatigue   17/20 (85.00%)  17
Pain   16/20 (80.00%)  16
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Lillian Siu
Organization: Univerisity Health Network
Phone: 416-946-2911
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00603915     History of Changes
Other Study ID Numbers: NPC-774
NPC-774
First Submitted: January 17, 2008
First Posted: January 29, 2008
Results First Submitted: May 6, 2011
Results First Posted: August 10, 2011
Last Update Posted: February 28, 2019