Trial Outcomes & Findings for Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer (NCT NCT00383331)
NCT ID: NCT00383331
Last Updated: 2009-06-03
Results Overview
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Results posted on
2009-06-03
Participant Flow
Participant milestones
| Measure |
21-Day Cycle
Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
|
14-Day Cycle
Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
21-Day Cycle
Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
|
14-Day Cycle
Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
21-Day Cycle
n=10 Participants
Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
|
14-Day Cycle
n=9 Participants
Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70.5 years
n=99 Participants
|
63.0 years
n=107 Participants
|
66.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group Performance Score
0 - Fully Active
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group Performance Score
1 - Ambulatory, Restricted Strenuous Activity
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group Performance Score
2 - Amublatory, No Work Activities
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group Performance Score
3 - Partially Confined to Bed, Limited Self Care
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Eastern Cooperative Oncology Group Performance Score
4 - Completely Disabled
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Previous Radiation Therapy
Yes
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Previous Radiation Therapy
No
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Stage of Lung Cancer
IIIB with pleural effusion
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Stage of Lung Cancer
IV
|
8 participants
n=99 Participants
|
7 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Tumor Cell Type
Squamous
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Tumor Cell Type
Adenocarcinoma
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Tumor Cell Type
Non-Small Cell Lung, Not Otherwise Specified (NOS)
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Tumor Cell Type
Other
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-upBest response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Outcome measures
| Measure |
21-Day Cycle
n=10 Participants
Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
|
14-Day Cycle
n=8 Participants
Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
|
|---|---|---|
|
Best Overall Tumor Response
Complete Response
|
0 participants
|
0 participants
|
|
Best Overall Tumor Response
Partial Response
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-upbaseline to measured progressive disease
Outcome measures
| Measure |
21-Day Cycle
n=10 Participants
Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
|
14-Day Cycle
n=8 Participants
Pemetrexed and Gemcitabine Day 1, every 14 days x 9 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: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-upTime to progressive disease not analyzed because trial was stopped early due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-upDuration of response was not analyzed because the trial was stopped early due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-upTime to treatment failure was not analyzed because the trial was stopped early due to low enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-upSurvival time is defined as the time from date of randomization to death due to any cause.
Outcome measures
| Measure |
21-Day Cycle
n=10 Participants
Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
|
14-Day Cycle
n=8 Participants
Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
|
|---|---|---|
|
Overall Survival
|
5.1 months
Interval 2.4 to 14.2
|
8.1 months
Interval 5.5 to 10.1
|
Adverse Events
21-Day Cycle
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
14-Day Cycle
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
21-Day Cycle
Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
|
14-Day Cycle
Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Ischemia-Cerebral
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression - Death
|
20.0%
2/10 • Number of events 2
|
0.00%
0/9
|
|
General disorders
Fatigue
|
0.00%
0/10
|
22.2%
2/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
2/10 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
General disorders
Pain - Extremity
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
Other adverse events
| Measure |
21-Day Cycle
Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
|
14-Day Cycle
Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10
|
77.8%
7/9
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
70.0%
7/10
|
22.2%
2/9
|
|
Gastrointestinal disorders
Diarrhea-No Colostom
|
40.0%
4/10
|
22.2%
2/9
|
|
Psychiatric disorders
Anorexia
|
20.0%
2/10
|
33.3%
3/9
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10
|
22.2%
2/9
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia NOS
|
0.00%
0/10
|
44.4%
4/9
|
|
Infections and infestations
Pruritis
|
30.0%
3/10
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10
|
11.1%
1/9
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10
|
22.2%
2/9
|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
8/10
|
88.9%
8/9
|
|
Blood and lymphatic system disorders
Leukopenia
|
80.0%
8/10
|
88.9%
8/9
|
|
Blood and lymphatic system disorders
Neutropenia
|
60.0%
6/10
|
66.7%
6/9
|
|
General disorders
Fatigue
|
60.0%
6/10
|
44.4%
4/9
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60