A Phase II Study of Cabozantinib versus Paclitaxel to Treat Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Protocol
13-048
Full Title
A Randomized Phase II Study of NCI Supplied Cabozantinib (NSC #761968 IND #116059) Versus Weekly Paclitaxel (NSC #673089) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (GOG-0186K)
Phase
II
Purpose

Paclitaxel is one of the chemotherapy drugs used in the standard treatment of ovarian, fallopian tube, or primary peritoneal cancer that has returned or has persisted despite prior treatment. However, it is not always curative, so researchers are seeking new therapies for women with these cancers.

Cabozantinib is an investigational drug that blocks the formation of new blood vessels that tumors need to grow and spread, by targeting several proteins that help keep cancer cells alive. It has been shown in other clinical trials to be active against certain cancers (including ovarian cancer). It is a capsule that is taken orally (by mouth).

In this Gynecologic Oncology Group study, researchers are comparing daily cabozantinib to weekly paclitaxel to treat women with ovarian, fallopian tube, or primary peritoneal cancer that has returned or has persisted despite prior treatment. Women will be randomly assigned to receive either paclitaxel (given by vein) or cabozantinib.

Eligibility

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

  • Patients must have ovarian, fallopian tube, or primary peritoneal cancer that has returned or has persisted despite prior treatment that included at least one regimen of platinum-based chemotherapy.
  • Patients may not have had more than three prior regimens of chemotherapy for advanced disease.
  • Patients may not have previously received weekly paclitaxel for recurrent or persistent disease, nor prior treatment with cabozantinib.
  • Patients must have recovered from the serious side effects of prior treatment. At least 1 week must have passed since the completion of hormonal therapy, 3 weeks since chemotherapy, and 4 weeks since radiation therapy and entry into the study.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Vicky Makker at 646-888-4224.

Disease(s)
Ovarian Cancer
Related Diseases