Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
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. 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.
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Drug: elesclomol sodium
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE II EVALUATION OF ELESCLOMOL SODIUM AND WEEKLY PACLITAXEL IN THE TREATMENT OF RECURRENT OR PERSISTENT PLATINUM-RESISTANT OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER|
- Frequency of objective response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Duration of objective response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Frequency of observed adverse effects defined as any unfavorable and unintended sign, symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Severity of observed adverse effects graded using the NCI CTCAE version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]Characterized by Kaplan-Meier plots.
- Overall survival [ Time Frame: From start of treatment to time of death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]Characterized by Kaplan-Meier plots.
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||January 2100 (Final data collection date for primary outcome measure)|
Experimental: Treatment (elesclomol sodium, paclitaxel)
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.
Drug: elesclomol sodium
Other Name: STA-4783Drug: paclitaxel
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.
I. To estimate the progression-free survival and overall survival of patients treated with elesclomol and paclitaxel.
OUTLINE: This is a multicenter study.
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.