This phase II trial studies how well elesclomol sodium and paclitaxel work in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after a period of improvement (recurrent) or is persistent. 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, by stopping them from dividing, or by stopping them from spreading. Elesclomol sodium may also help paclitaxel work better by making tumor cells more sensitive to the drug.
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 this cohort of patients. SECONDARY OBJECTIVES: I. To estimate the progression-free survival and overall survival of patients treated with elesclomol and paclitaxel. OUTLINE: Patients receive paclitaxel intravenously (IV) over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Given IV
Given IV
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
University of California San Diego
San Diego, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Proportion of Participants With Objective Response
Proportion of Participants with Object Response (per response evaluation criteria in solid tumors criteria (RECIST V1.1) for target lesions as assessed by MRI: Complete Response (CR), disappearance of all target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 5 years
Duration of Objective Response
Duration of objective response (months)
Time frame: Up to 5 years
Number of Participants Who Experienced at Least One Adverse Event
The frequency of patients who experienced at least one adverse effect (with a grade of 1 or higher). Adverse effects are 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
The Number of Participants Who Experienced at Least One Grade 3 Adverse Event
The number of participants who experienced at least one grade three (or higher) adverse effect. The severity of observed adverse effects is graded using the NCI CTCAE version 4.0.
Time frame: Up to 5 years
Progression-free Survival (Median)
Progression-free survival (median, in months) will be analyzed by Kaplan-Meier analysis (progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (also a 5 mm absolute increase is also required), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
Overall Survival (Median)
Overall survival (median, in months) will be analyzed by Kaplan-Meier analysis.
Time frame: From start of treatment to time of death or the date of last contact, assessed up to 5 years
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Aurora, Colorado, United States
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