Last updated on December 2014

Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer


Brief description of study

This phase II trial studies how well giving elesclomol sodium together with paclitaxel works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving elesclomol together with paclitaxel may kill more tumor cells.

Detailed Study Description

PRIMARY OBJECTIVES: I. To estimate the antitumor activity of elesclomol (elesclomol sodium) and paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer primarily through the frequency of objective tumor responses. II. To determine the nature and degree of toxicity of elesclomol and paclitaxel in these patients. SECONDARY OBJECTIVES: I. To estimate the progression-free survival and overall survival of patients treated with elesclomol and paclitaxel. OUTLINE: Patients receive elesclomol sodium intravenously (IV) over 1 hour and paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Clinical Study Identifier: NCT00888615

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James L. Wade

Saint Francis Medical Center
Cape Girardeau, MO United States
3.29miles
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