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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

  • Duration of objective response [ Time Frame: Up to 5 years ]
  • Frequency of objective response using RECIST version 1.1 [ Time Frame: Up to 5 years ]
  • 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 ]
    The frequency of all toxicities are tabulated from submitted case report forms and summarized for review.
  • Severity of observed adverse effects graded using the NCI CTCAE version 4.0 [ Time Frame: Up to 5 years ]
    The severity of all toxicities are tabulated from submitted case report forms and summarized for review.


Original Primary Outcome:

  • Frequency and duration of objective response
  • Frequency and severity of observed adverse effects


Current Secondary Outcome:

  • Overall survival [ Time Frame: From start of treatment to time of death or the date of last contact, assessed up to 5 years ]
    Characterized by Kaplan-Meier plots.
  • Progression-free survival using RECIST version 1.1 [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ]
    Characterized by Kaplan-Meier plots.


Original Secondary Outcome: Duration of progression-free survival and overall survival

Information By: Gynecologic Oncology Group

Dates:
Date Received: April 24, 2009
Date Started: December 2010
Date Completion:
Last Updated: May 2, 2017
Last Verified: May 2017