Trial Outcomes & Findings for Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer (NCT NCT00394147)
NCT ID: NCT00394147
Last Updated: 2022-08-05
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
1 year
Results posted on
2022-08-05
Participant Flow
Participant milestones
| Measure |
Pemetrexed and Gemcitabine
pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
pemetrexed: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
gemcitabine: gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed and Gemcitabine
n=17 Participants
pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
pemetrexed: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
gemcitabine: gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPer 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 and Gemcitabine
n=17 Participants
pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
pemetrexed: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
gemcitabine: gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
|
|---|---|
|
Objective Response Rate
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Pemetrexed and Gemcitabine
n=17 Participants
pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
pemetrexed: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
gemcitabine: gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
|
|---|---|
|
Time to Progression
|
5.9 months
Interval 0.4 to 23.5
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Pemetrexed and Gemcitabine
n=17 Participants
pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
pemetrexed: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
gemcitabine: gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
|
|---|---|
|
Overall Survival
|
5.9 months
Interval 2.8 to 11.9
|
Adverse Events
Pemetrexed and Gemcitabine
Serious events: 4 serious events
Other events: 17 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Pemetrexed and Gemcitabine
n=17 participants at risk
pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
pemetrexed: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
gemcitabine: gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
|
|---|---|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.8%
2/17 • 1 year
Through study completion, an average of 1 year
|
|
General disorders
Pain from worsening spinal metastases
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
Other adverse events
| Measure |
Pemetrexed and Gemcitabine
n=17 participants at risk
pemetrexed 500mg/m2 and gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
pemetrexed: pemetrexed 500mg/m2 given on day 1 and day 15 of each 28 day cycle
gemcitabine: gemcitabine 1500mg/m2 given on day 1 and day 15 of each 28 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
88.2%
15/17 • 1 year
Through study completion, an average of 1 year
|
|
General disorders
Pain
|
70.6%
12/17 • 1 year
Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
70.6%
12/17 • 1 year
Through study completion, an average of 1 year
|
|
General disorders
Fatigue
|
64.7%
11/17 • 1 year
Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
58.8%
10/17 • 1 year
Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Cough
|
52.9%
9/17 • 1 year
Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
47.1%
8/17 • 1 year
Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Constipation
|
41.2%
7/17 • 1 year
Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Nausea or vomiting
|
41.2%
7/17 • 1 year
Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Xerostomia
|
41.2%
7/17 • 1 year
Through study completion, an average of 1 year
|
|
General disorders
Edema
|
35.3%
6/17 • 1 year
Through study completion, an average of 1 year
|
|
Psychiatric disorders
Insomnia
|
35.3%
6/17 • 1 year
Through study completion, an average of 1 year
|
|
Nervous system disorders
Myalgia arthralgia
|
35.3%
6/17 • 1 year
Through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea/Shortness of breath
|
35.3%
6/17 • 1 year
Through study completion, an average of 1 year
|
|
Investigations
Alkaline phosphatase
|
35.3%
6/17 • 1 year
Through study completion, an average of 1 year
|
|
Investigations
Increased LFTs
|
35.3%
6/17 • 1 year
Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
35.3%
6/17 • 1 year
Through study completion, an average of 1 year
|
|
Infections and infestations
White blood cell count decreased
|
29.4%
5/17 • 1 year
Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
29.4%
5/17 • 1 year
Through study completion, an average of 1 year
|
|
General disorders
Fever
|
23.5%
4/17 • 1 year
Through study completion, an average of 1 year
|
|
General disorders
Chills
|
23.5%
4/17 • 1 year
Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.5%
4/17 • 1 year
Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Dry cracked skin
|
23.5%
4/17 • 1 year
Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Heartburn
|
23.5%
4/17 • 1 year
Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
4/17 • 1 year
Through study completion, an average of 1 year
|
|
Nervous system disorders
Neuropathy- Sensory
|
23.5%
4/17 • 1 year
Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.5%
4/17 • 1 year
Through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Mucositis
|
23.5%
4/17 • 1 year
Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.6%
3/17 • 1 year
Through study completion, an average of 1 year
|
|
General disorders
Hemorrhage
|
17.6%
3/17 • 1 year
Through study completion, an average of 1 year
|
|
Psychiatric disorders
Depression
|
17.6%
3/17 • 1 year
Through study completion, an average of 1 year
|
|
Nervous system disorders
Neuropathy-Motor
|
17.6%
3/17 • 1 year
Through study completion, an average of 1 year
|
|
Infections and infestations
Infection (w/o neutropenia)
|
17.6%
3/17 • 1 year
Through study completion, an average of 1 year
|
|
Investigations
Hypercalcemia
|
17.6%
3/17 • 1 year
Through study completion, an average of 1 year
|
|
Investigations
Hyperkalemia
|
17.6%
3/17 • 1 year
Through study completion, an average of 1 year
|
|
Nervous system disorders
Dysgeusia
|
17.6%
3/17 • 1 year
Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.6%
3/17 • 1 year
Through study completion, an average of 1 year
|
|
Vascular disorders
Orthostatic Hypotension
|
11.8%
2/17 • 1 year
Through study completion, an average of 1 year
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • 1 year
Through study completion, an average of 1 year
|
|
Psychiatric disorders
Anxiety
|
11.8%
2/17 • 1 year
Through study completion, an average of 1 year
|
|
Eye disorders
Epiphora
|
11.8%
2/17 • 1 year
Through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Weight Loss
|
11.8%
2/17 • 1 year
Through study completion, an average of 1 year
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • 1 year
Through study completion, an average of 1 year
|
|
Renal and urinary disorders
Creatinine
|
11.8%
2/17 • 1 year
Through study completion, an average of 1 year
|
|
Investigations
Hypomagnesia
|
11.8%
2/17 • 1 year
Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Platelets
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
General disorders
Dizziness
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
General disorders
Weakness
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
Nervous system disorders
Ataxia
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
Infections and infestations
Infection with neutropenia
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
1/17 • 1 year
Through study completion, an average of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place