A Phase III Study of Doxil Alone and with Yondelis (Trabectedin) in Women with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Protocol
13-153
Full Title
A Randomized, Open-Label Study Comparing the Combination of YONDELIS® and DOXIL®/CAELYX® With DOXIL®/CAELYX® Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Phase
III
Purpose

Doxil (pegylated liposomal doxorubicin) is a drug approved for the treatment of ovarian, fallopian tube, and primary peritoneal cancers. However, the cancer may continue to grow despite this therapy.

In this study, researchers want to see if adding the drug Yondelis (trabectedin) to Doxil therapy is more effective than Doxil alone in women with ovarian, fallopian tube, or primary peritoneal cancers that have persisted or returned despite prior therapy. Yondelis is approved in Europe for the treatment of sarcoma, but its use in this study is considered investigational. It works by disrupting the DNA of cancer cells.

Patients will be randomly assigned to receive Doxil alone or Doxil plus Yondelis. Both drugs are given intravenously (by vein). Researchers will also study whether having a BRCA gene mutation influences how a patient responds to therapy.

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 persisted or returned despite one or two regimens of prior therapy that included a platinum-containing drug.
  • At least 3 weeks must have passed since completion of prior treatment and entry into 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 women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Roisin O’Cearbhaill at 646-888-4227.

Disease(s)
Locations
Related Diseases