Phase I Study of Olaparib in Combination with Chemotherapy in Patients Newly Diagnosed with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Protocol
10-220
Full Title
A Phase 1 Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
Phase
I
Purpose

Olaparib is an investigational drug that kills cancer cells by blocking the PARP protein, thereby preventing the repair of DNA or genetic damage in cancer cells and possibly making them more vulnerable to anticancer treatments. Prior research has shown that olaparib may be active against ovarian cancer. Olaparib is taken orally (by mouth).

In this study, researchers want to identify the highest dose of olaparib that can be given safely in combination with other chemotherapy drugs in patients newly diagnosed with ovarian, fallopian tube, or primary peritoneal cancer. In addition to olaparib, patients will receive cisplatin (given intraperitoneally — into the abdomen through a port), paclitaxel (given intravenously or intraperitoneally), and bevacizumab (given intravenously).

Doctors also want to see if a patient’s BRCA mutation status affects the way they respond to treatment.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer.
  • Patients must have had their initial cancer surgery no more than 12 weeks before entering the study.
  • Patients may not have previously received chemotherapy for their cancer, nor radiation therapy to the pelvis or prior treatment with bevacizumab or a PARP inhibitor.
  • This study is for women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Jason Konner at 646-888-4219.

Disease(s)
Ovarian Cancer
Locations
Related Diseases