Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma
- Before patients receive any chemotherapy treatments they will be given three
medications to prevent side effects from the chemotherapy drugs. These medications are
vitamin B12, folic acid and dexamethasone.
- Chemotherapy treatments will be given intravenously in the outpatient clinic.
Pemetrexed will be given first and will take 10 minutes to infuse followed by
carboplatin which will take 30-45 minutes to infuse. These treatments will be repeated
once every three weeks for 6 cycles of chemotherapy (18 weeks).
- Before each chemotherapy treatment the following tests and procedures will be
performed: physical exam and medical history; evaluation of ability to undertake daily
activities; and blood tests.
- After every 2 cycles of chemotherapy (every 6 weeks) patients will have a CT or MRI
scan to measure how well their cancer is responding to treatment.
- The study treatment will last for 6 cycles of chemotherapy as long as the tumor does
not grow and the patient isn't experiencing any severe side effects.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the response rate of combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in recurrent ovarian, primary peritoneal, and fallopian tube carcinoma.
2 years
No
Dennis Yi-Shin Kuo, MD
Principal Investigator
Montefiore Medical Center
United States: Institutional Review Board
MMC-08-04-097
NCT01001910
April 2008
April 2014
Name | Location |
---|---|
Montefiore Medical Center | Bronx, New York 10467-2490 |