A Phase II Study of Pegylated Liposomal Doxorubicin Alone or with VTX-2337 in Women with Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Protocol
13-041
Full Title
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of VTX-2337 in Combination with Pegylated Liposomal Doxorubicin (PLD) in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (GOG 3003)
Phase
II
Disease Status
Newly Diagnosed & Relapsed/Refractory
Purpose

Pegylated liposomal doxorubicin (PLD) is one of the standard chemotherapy drugs used to treat ovarian, fallopian tube, or primary peritoneal cancer. The purpose of this study is to see if adding the investigational drug VTX-2337 to PLD therapy is more effective than PLD alone in women with ovarian, fallopian tube, or primary peritoneal cancer that has returned or persists despite prior therapy.

VTX-2337, which is given as a subcutaneous (under the skin) injection, stimulates the immune system and may help the body kill cancer cells. PLD is given intravenously (by vein). Patients in this study will be randomly assigned to receive PLD plus VTX-2337 or PLD with a placebo injection. This study is being conducted 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 one or two prior regimens of chemotherapy, at least one of which included a platinum-containing drug.
  • At least 3 weeks must have passed since completion of previous chemotherapy and 4 weeks since radiation therapy and entry into the study.
  • Patients may not have had previous VTX-2337, doxorubicin, PLD, or other anthracycline therapy.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mario Leitao at 212-639-3987.

Disease(s)
Locations
Related Diseases