Trial Outcomes & Findings for A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas (NCT NCT02868892)
NCT ID: NCT02868892
Last Updated: 2018-11-02
Results Overview
Evaluate the progression free survival of recurrent cervical adenocarcinoma. Progression-Free Survival is defined as the period of time from the date of first study drug administration to the date that the subject is determined to have progressive disease or death due to any cause.
TERMINATED
PHASE2
6 participants
2 years
2018-11-02
Participant Flow
Participant milestones
| Measure |
Pemetrexed
Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.
Pemetrexed: Pemetrexed 500 mg/m2
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Pemetrexed
Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.
Pemetrexed: Pemetrexed 500 mg/m2
|
|---|---|
|
Overall Study
Investigator left site and no follow-up
|
6
|
Baseline Characteristics
A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=6 Participants
Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.
Pemetrexed: Pemetrexed 500 mg/m2
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
54 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.
Evaluate the progression free survival of recurrent cervical adenocarcinoma. Progression-Free Survival is defined as the period of time from the date of first study drug administration to the date that the subject is determined to have progressive disease or death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.
Evaluate the response rate for recurrent cervical adenocarcinomas treated with pemetrexed. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension which must have been 20 mm when measured by conventional techniques including palpation, plain X-ray, CT, and MRI or 10 mm when measured by spiral CT.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.
Evaluate Overall survival for recurrent cervical adenocarcinomas treated with pemetrexed.
Outcome measures
Outcome data not reported
Adverse Events
Pemetrexed
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place