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Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00293579
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Anterpreet Neki, Ohio State University Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Intervention Drug: Pemetrexed
Enrollment 5
Recruitment Details Patients were enrolled to the study from March 2006 to January 2008
Pre-assignment Details  
Arm/Group Title Pemetrexed
Hide Arm/Group Description pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Period Title: Overall Study
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Pemetrexed
Hide Arm/Group Description pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
52
(49 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
2
  40.0%
Male
3
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Overall Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: patients
0
2.Secondary Outcome
Title Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer
Hide Description Drug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percent of patients
fatigue 80
Hypercalcemia 20
Anemia 20
3.Secondary Outcome
Title Impact of Pemetrexed Chemotherapy on Quality of Life
Hide Description Quality of life assessements conducted at BL (baseline assessment) and EoT (End of treatment). University of Washington QOL (UW-QOL) questionnaire tests 9 specific areas relating to head and neck cancer. A composite score is calculated by adding together the 9 domain scores to give a scale from 0 (for poor health) to 900 (good health).
Time Frame Baseline, End of Treatment [up to 3 years]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pemetrexed
Hide Arm/Group Description:

pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles

Pemetrexed: 500 mg/m2 IV every 3 weeks for 6 cycles

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline score 524  (141.6)
End of Treatment score 335.5  (185.9)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was measured from the time of initial study entry to death due to any cause.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients were deceased at the time of terminating this study.
Arm/Group Title Pemetrexed
Hide Arm/Group Description:
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: months
4.4
(1.4 to 15.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed
Hide Arm/Group Description pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
All-Cause Mortality
Pemetrexed
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pemetrexed
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Cardiac disorders   
Rapid Heart rate  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Nausea  1  4/5 (80.00%)  4
Vomiting  1  2/5 (40.00%)  2
Diarrhea  1  1/5 (20.00%)  1
Constipation  1  3/5 (60.00%)  3
Increased/Thicker saliva  1  2/5 (40.00%)  2
Gum pain  1  1/5 (20.00%)  1
Abdominal pain  1  1/5 (20.00%)  1
Stomach Pain  1  1/5 (20.00%)  1
General disorders   
Fatigue  1  5/5 (100.00%)  5
Infections and infestations   
Pneumonia  1  2/5 (40.00%)  2
Conjunctivitis  1  1/5 (20.00%)  1
Investigations   
Alkaline phosphatase  1  1/5 (20.00%)  1
ALT  1  1/5 (20.00%)  1
AST  1  1/5 (20.00%)  1
Gamma-Glutamyl transpeptidase  1  1/5 (20.00%)  1
Metabolism and nutrition disorders   
Hypercalcemia  1  1/5 (20.00%)  1
Anorexia  1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Body jerking  1  1/5 (20.00%)  1
Neck pain  1  2/5 (40.00%)  2
Loss of balance  1  1/5 (20.00%)  1
Nervous system disorders   
Headache  1  1/5 (20.00%)  1
Disorientation  1  1/5 (20.00%)  1
Renal and urinary disorders   
Increased urination  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Increased secretions  1  1/5 (20.00%)  1
Vocal changes  1  1/5 (20.00%)  1
Upper Respiratory Infection  1  1/5 (20.00%)  1
Vascular disorders   
Bleeding from Tumor  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE version 3
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Anterpreet Neki
Organization: Ohio State University Comprehensive Cancer Center
Phone: 614-257-2900
Responsible Party: Anterpreet Neki, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00293579     History of Changes
Other Study ID Numbers: OSU-0482
First Submitted: February 15, 2006
First Posted: February 17, 2006
Results First Submitted: October 30, 2015
Results First Posted: March 10, 2016
Last Update Posted: March 10, 2016