The purpose of this study is to determine the effects (good and bad) the combination of carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian tube cancer.
* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Given intravenously following pemetrexed over 30-45 minutes once every three weeks for 6 cycles (18 weeks)
Given intravenously over 30 minutes once every three weeks for 6 cycles (18 weeks)
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
To assess the response rate of carboplatin in combination with pemetrexed in patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer.
This study has now been published: Matulonis U.A.,Horowitz N, Campos S, Lee H., Lee J., Krasner C., Berlin S., Roche M., Duska L, Pereira L, Kendall D, Penson R. Phase II Study of Carboplatin and Pemetrexed for the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer. J Clin Oncol. 2008:26(35):5761-6
Time frame: 2 years
To assess time to progression, progression-free survival, and overall survival in this patient population
to assess toxicities of treatment with combination carboplatin and pemetrexed.
Time frame: 2 years
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