Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
RATIONALE: 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.
PURPOSE: This phase II trial is studying the side effects of giving elesclomol sodium together with paclitaxel and to see how well it works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: elesclomol sodium
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Elesclomol and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Sponsor: GOG, IND# 110072)|
- Frequency and duration of objective response [ Designated as safety issue: No ]
- Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]
- Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
- To estimate the antitumor activity of elesclomol sodium and paclitaxel, in terms of the frequency of objective tumor responses, in patients with persistent or recurrent platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- To determine the nature and degree of toxicity of elesclomol sodium and paclitaxel in these patients.
- To estimate the progression-free survival and overall survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive elesclomol sodium 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.