A Phase III Study of Doxil with and without Vintafolide in Women with Platinum-Resistant Ovarian Cancer

Protocol
13-046
Full Title
A Randomized Double-Blind Phase 3 Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/DOXIL®/CAELYX®) In Combination Versus PLD In Participants With Platinum-Resistant Ovarian Cancer
Phase
III
Purpose

Pegylated liposomal doxorubicin (Doxil) is a standard chemotherapy drug used to treat ovarian cancer that has continued to grow or has returned after therapy that included a platinum-containing drug. However, in some patients the cancer continues to grow. Doctors are therefore seeking more effective treatments for this cancer.

Vintafolide (EC145) is an investigational drug composed of folic acid — which attaches to folate receptors on cancer cells — and vinca, a chemotherapy drug which kills cancer cells. In this study, researchers want to see if giving Doxil with vintafolide is more effective for treating platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer than Doxil alone.

Patients will be randomly assigned to receive Doxil plus vintafolide or Doxil plus a placebo (inactive liquid). Each treatment is given intravenously (by vein). In addition to treatment effectiveness, researchers will also be looking at the effects of therapy on patients’ quality of life.

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 spread despite one or two prior regimens of treatment that included platinum-based chemotherapy. Patients’ disease must have returned or continued to grow within 6 months of completing this chemotherapy.
  • Patients should have recovered from the serious side effects of prior therapy before entering the study.
  • 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. Jason Konner at 646-888-4219.

Disease(s)
Ovarian Cancer
Locations
Related Diseases