Phase I/II Study of Carboplatin and Pralatrexate in Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer
- Since we are looking for the highest dose of the study drug that can be administered
safely without severe or unmanageable side effects, not everyone who participates will
receive the same dose of the study drug.
- Each study cycle will last 28 days. On Day 1, participants will receive carboplatin
intravenously. On Days 1 and 15 of each cycle they will receive pralatrexate
intravenously. Participants will also be asked to take folic acid orally on a daily
basis starting 7 days before the first dose of pralatrexate and continuing until 30
days after the last dose of pralatrexate. They will also receive a vitamin B12
injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10
weeks after the first dose of pralatrexate.
- Participants will come to the clinic on Day 1 and 15 of each cycle and have the
following tests/procedures performed: Medical history; Vital signs; Blood tests,
assessment of the tumor (every two cycles) and an EKG (before the start of cycle 2).
- In addition, during Cycle 1, participants will come to the clinic weekly for blood
- Pharmacokinetic (PK) blood samples (to monitor how the body absorbs and breaks down the
study drug) will be done at the following time points during Cycle 1: Day 1-3 and Day
- Participants will be asked to take the study drugs for up to 6 cycles. They may
continue beyond 6 cycles as long as there is evidence that the tumor is not growing and
they are not experiencing any unacceptable side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
To identify the maximum tolerated dose of Pralatrexate in combination with carboplatin in this patient population.
Marcela G. del Carmen, MD, MPH
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|