Trial Outcomes & Findings for Pemetrexed Disodium and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00407550)
NCT ID: NCT00407550
Last Updated: 2019-05-02
Results Overview
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. \> \> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Two consecutive evaluations at least 6 weeks apart (up to 2 years)
Results posted on
2019-05-02
Participant Flow
19 patients were enrolled from 9 medical clinics between November 3, 2006 and August 10, 2007.
Participant milestones
| Measure |
Gemzar x2
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
|
Gemzar x1
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Gemzar x2
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
|
Gemzar x1
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Insurance or Other medical condition
|
2
|
1
|
Baseline Characteristics
Pemetrexed Disodium and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Gemzar x2
n=10 Participants
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
|
Gemzar x1
n=9 Participants
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.5 Years
n=5 Participants
|
63 Years
n=7 Participants
|
66 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Performance Score
0 - Fully Active
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Performance Score
1 - Ambulatory, restricted strenuous activity
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Lung Stage
IV - Distant Metastasis
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Lung Stage
IIIB w/pleural effusion - N3 or T4
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two consecutive evaluations at least 6 weeks apart (up to 2 years)Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. \> \> Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
Outcome measures
| Measure |
Gemzar x2
n=10 Participants
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
|
Gemzar x1
n=9 Participants
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
|
|---|---|---|
|
Number of Patients With Confirmed Responses
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Time from registration to progression or death (up to 2 years)Population: One patient in Arm B was deemed a protocol violation and was not include din this analysis.
Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.
Outcome measures
| Measure |
Gemzar x2
n=10 Participants
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
|
Gemzar x1
n=8 Participants
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
|
|---|---|---|
|
Progression-free Survival
|
1.66 months
Interval 0.69 to 4.3
|
5.04 months
Interval 1.74 to 5.95
|
SECONDARY outcome
Timeframe: Death or last follow-up (up to 2 years)Population: One patient in Arm B was a major violation and not included in this analysis.
Overall survival time was defined as the number of months from registration to the date of death or last follow-up
Outcome measures
| Measure |
Gemzar x2
n=10 Participants
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
|
Gemzar x1
n=8 Participants
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
|
|---|---|---|
|
Overall Survival
|
5.1 months
Interval 2.14 to 14.2
|
8.1 months
Interval 5.5 to 10.1
|
SECONDARY outcome
Timeframe: Gemzar x2 Arm every 21 days, Gemzar x1 Arm every 14 days (up to 2 years)Population: All patients that began protocol treatment are included in this analysis.
Number of patients that experienced adverse events (grade 4 or more) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0
Outcome measures
| Measure |
Gemzar x2
n=10 Participants
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
|
Gemzar x1
n=9 Participants
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
|
|---|---|---|
|
Adverse Event
|
6 Participants
|
4 Participants
|
Adverse Events
Gemzar x2
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Gemzar x1
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemzar x2
n=10 participants at risk
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
|
Gemzar x1
n=9 participants at risk
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Number of events 2
|
11.1%
1/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Disease Progression
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Fatigue
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Blood Infection
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Skin (cellulites) infection
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Investigations
INR increased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Leukopenia
|
20.0%
2/10 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Lymphopenia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Neutrophil count decreased
|
30.0%
3/10 • Number of events 5
|
33.3%
3/9 • Number of events 3
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10
|
11.1%
1/9 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
Other adverse events
| Measure |
Gemzar x2
n=10 participants at risk
Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
|
Gemzar x1
n=9 participants at risk
Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
8/10 • Number of events 29
|
88.9%
8/9 • Number of events 36
|
|
Cardiac disorders
Edema
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Eye disorders
Vision-Double
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Eye disorders
Watering eyes
|
10.0%
1/10 • Number of events 2
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Number of events 4
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • Number of events 9
|
22.2%
2/9 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10
|
11.1%
1/9 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Number of events 11
|
77.8%
7/9 • Number of events 20
|
|
Gastrointestinal disorders
Oral cavity Mucositis/stomatitis (clinical exam)
|
0.00%
0/10
|
11.1%
1/9 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 3
|
22.2%
2/9 • Number of events 4
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Disease Progression
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Fatigue
|
60.0%
6/10 • Number of events 10
|
66.7%
6/9 • Number of events 12
|
|
General disorders
Pain
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Lung (pneumonia) infection
|
10.0%
1/10 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10
|
33.3%
3/9 • Number of events 3
|
|
Investigations
Creatinine increased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Forced expiratory volume decreased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Investigations
INR increased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Leukopenia
|
90.0%
9/10 • Number of events 27
|
88.9%
8/9 • Number of events 23
|
|
Investigations
Lymphopenia
|
10.0%
1/10 • Number of events 7
|
0.00%
0/9
|
|
Investigations
Neutrophil count decreased
|
70.0%
7/10 • Number of events 19
|
88.9%
8/9 • Number of events 29
|
|
Investigations
Platelet count decreased
|
70.0%
7/10 • Number of events 12
|
22.2%
2/9 • Number of events 3
|
|
Investigations
Vital capacity decreased
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Investigations
Weight loss
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
2/10 • Number of events 2
|
33.3%
3/9 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10
|
11.1%
1/9 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Number of events 2
|
0.00%
0/9
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Ischemia cerebrovascular
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Taste
|
10.0%
1/10 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 2
|
22.2%
2/9 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
2/10 • Number of events 2
|
11.1%
1/9 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
3/10 • Number of events 3
|
11.1%
1/9 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Vascular disorders
Phlebitis
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Vascular disorders
Thrombosis
|
10.0%
1/10 • Number of events 2
|
0.00%
0/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place