Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Ursula Matulonis, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|