A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas
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|ClinicalTrials.gov Identifier: NCT02868892|
Recruitment Status : Terminated (departure of PI from institution and poor population for study participation)
First Posted : August 16, 2016
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Cervix Adenosquamous Cell Carcinoma of the Cervix||Drug: Pemetrexed||Phase 2|
Patients will receive Pemetrexed 500 mg/m2 every three week.
On initiation of pemetrexed, on day one of first chemotherapy cycle, patients will begin taking folic acid at a dose of 350 to 600 mcg daily as well as receive an intramuscular injection of 1000 mcg of vitamin B12, with subsequent vitamin B12 injections given every 9 weeks while on study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pemetrexed in Recurrent Cervical Adenocarcinomas|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
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 500 mg/m2
Other Name: Alimta
- Progression Free Survival [ Time Frame: 2 years ]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.
- Response Rate [ Time Frame: 2 years ]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.
- Overall Survival [ Time Frame: 2 years ]Evaluate Overall survival for recurrent cervical adenocarcinomas treated with pemetrexed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868892
|United States, Arizona|
|Western Regional Medical Center, Inc.|
|Goodyear, Arizona, United States, 85338|
|Principal Investigator:||John Farley, MD||Western Regional Medical Center|