A Phase I Study of Pegylated Liposomal Doxorubicin, Carboplatin, and Veliparib in Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Protocol
12-197
Full Title
A Phase I Trial of Pegylated Liposomal Doxorubicin(PLD) Carboplatin, NCI Supplied Veliparib (ABT-888) and NCI Supplied Bevacizumab in Recurrent Platinum Sensitive Ovarian, Primary Peritoneal and Fallopian Tube Cancer (GOG 9927)
Phase
I
Purpose

Doxil® (pegylated liposomal doxorubicin) is a standard chemotherapy drug used in women with ovarian, fallopian tube, or primary peritoneal cancer that persists despite treatment with other chemotherapy, such as paclitaxel and carboplatin. The purpose of this study is to find the highest dose of an investigational drug called veliparib (ABT-888) that can be given safely with Doxil and carboplatin in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer that has returned after initial therapy.

Veliparib is an investigational drug that kills cancer cells by preventing the repair of DNA or genetic damage in cancer cells, possibly making them more susceptible to anticancer drugs. It can also work well in cancer cells that do not have functional BRCA, a protein which helps to fix DNA damage. About 10 percent of ovarian cancer patients have mutations in BRCA genes. Veliparib is taken orally (by mouth).

This study is sponsored by the Gynecologic Oncology Group.

Eligibility

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

  • Patients must have epithelial ovarian, fallopian tube, or primary peritoneal cancer that returned after one regimen of treatment that included a platinum-based drug.
  • At least 6 months must have passed since completion of prior platinum-based treatment and entry into the study.
  • Patients who have had prior veliparib, Doxil, or radiation therapy to the abdomen or pelvis may not participate.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Katherine M. Bell-McGuinn at 646-888-4221.

Disease(s)
Ovarian Cancer
Locations
Related Diseases