A Phase I Study of VTX-2337 Plus Doxil in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Protocol
11-110
Full Title
A Phase I Study of VTX-2337 (IND #78,416) in Combination with Pegylated Liposomal Doxorubicin (PLD, NSC#712227) or in Combination with Weekly Paclitaxel (NSC#673089) in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (GOG-9925)
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 investigation drug called VTX-2337 that can be given safely with Doxil in women with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

VTX-2337 works by stimulating the immune system to help the body kill cancer cells. It is an injection given under the skin (subcutaneously). 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 has persisted or returned despite prior treatment that included a platinum-based drug.
  • At least 3 weeks must have passed since completion of prior treatment (1 week since prior hormonal therapy directed at the tumor) and entry into the study.
  • Patients with active auto-immune diseases may not be eligible to participate. Examples include lupus, inflammatory bowel disease, multiple sclerosis, and rheumatoid arthritis.
  • Patients must be age 18 or 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