A Phase III Study of AEZS-108 versus Doxorubicin as Second-Line Therapy for Recurrent or Metastatic Endometrial Cancer

Protocol
13-130
Full Title
Randomized Controlled Study Comparing AEZS-108 with Doxorubicin as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer
Phase
III
Purpose

Doxorubicin is a standard chemotherapy drug used to treat many types of cancer, including endometrial cancer. However, in some patients the cancer continues to grow. Doctors are therefore seeking more effective drugs for this cancer.

AEZS-108 is an investigational drug composed of doxorubicin plus a kind of hormone that helps doxorubicin stick to and enter docking sites for this hormone (called LHRH receptors). In this study, researchers are comparing the effectiveness of AEZS-108 with doxorubicin in women with endometrial cancer that has returned or spread after initial therapy. Patients will receive AEZS-108 or doxorubicin. Each drug is given intravenously (by vein).

Eligibility

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

  • Patients must have endometrial cancer that has returned or spread (stage III or IV) despite one prior regimen of therapy that included platinum/taxane-based chemotherapy.
  • At least 4 weeks must have passed since completion of previous therapy and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • 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)
Uterine (Endometrial) Cancer
Locations