Trial Outcomes & Findings for Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer (NCT NCT00293579)
NCT ID: NCT00293579
Last Updated: 2020-02-10
Results Overview
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.
COMPLETED
PHASE2
5 participants
Up to 3 years
2020-02-10
Participant Flow
Patients were enrolled to the study from March 2006 to January 2008
Participant milestones
| Measure |
Pemetrexed
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pemetrexed
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pemetrexed Chemotherapy in Poor-Risk Patients With Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=5 Participants
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
|
|---|---|
|
Age, Continuous
|
52 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPer 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.
Outcome measures
| Measure |
Pemetrexed
n=4 Participants
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
|
|---|---|
|
Overall Response Rate
|
0 patients
|
SECONDARY outcome
Timeframe: Up to 3 yearsDrug induced toxicities were assessed and graded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Outcome measures
| Measure |
Pemetrexed
n=5 Participants
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
|
|---|---|
|
Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer
fatigue
|
80 percent of patients
|
|
Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer
Hypercalcemia
|
20 percent of patients
|
|
Toxicities of Pemetrexed,in Poor Risk Cases With Poor Performance Status and Advanced, Metastatic, or Recurrent Head and Neck Cancer
Anemia
|
20 percent of patients
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment [up to 3 years]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).
Outcome measures
| Measure |
Pemetrexed
n=5 Participants
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
|
|---|---|
|
Impact of Pemetrexed Chemotherapy on Quality of Life
Baseline score
|
524 Units on a scale
Standard Deviation 141.6
|
|
Impact of Pemetrexed Chemotherapy on Quality of Life
End of Treatment score
|
335.5 Units on a scale
Standard Deviation 185.9
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All patients were deceased at the time of terminating this study.
Overall survival was measured from the time of initial study entry to death due to any cause.
Outcome measures
| Measure |
Pemetrexed
n=4 Participants
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
|
|---|---|
|
Overall Survival
|
4.4 months
Interval 1.4 to 15.4
|
Adverse Events
Pemetrexed
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pemetrexed
n=5 participants at risk
pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
80.0%
4/5 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Fatigue
|
100.0%
5/5 • Number of events 5
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Increased/Thicker saliva
|
40.0%
2/5 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Body jerking
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Gum pain
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Stomach Pain
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Loss of balance
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Increased secretions
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Increased urination
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Vocal changes
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Disorientation
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Rapid Heart rate
|
20.0%
1/5 • Number of events 1
|
|
Vascular disorders
Bleeding from Tumor
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Alkaline phosphatase
|
20.0%
1/5 • Number of events 1
|
|
Investigations
ALT
|
20.0%
1/5 • Number of events 1
|
|
Investigations
AST
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Gamma-Glutamyl transpeptidase
|
20.0%
1/5 • Number of events 1
|
Additional Information
Anterpreet Neki
Ohio State University Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place