Clinical Trial: A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Study of Pemetrexed in Recurrent Cervical Adenocarcinomas

Brief Summary: Patients with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix will receive Pemetrexed.

Detailed Summary:

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.


Sponsor: Western Regional Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Western Regional Medical Center

Dates:
Date Received: May 2, 2016
Date Started: July 2015
Date Completion: July 2018
Last Updated: August 11, 2016
Last Verified: August 2016