Clinical Trial: Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer

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

Official Title: A Phase II Trial of DCTD-Sponsored Dasatinib in Recurrent/Persistent Ovary, Fallopian Tube, Primary Peritoneal, and Endometrial Clear Cell Carcinoma Characterized for the

Brief Summary: This phase II trial studies how well dasatinib works in treating patients with ovarian, fallopian tube, endometrial, or peritoneal cancer that has come back or is persistent. Dasatinib may shrink patients' tumors by blocking some of the enzymes needed for cell growth.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the clinical activity of dasatinib in patients with recurrent or persistent ovarian, fallopian tube, primary peritoneal, and endometrial clear cell carcinoma using objective tumor response (complete and partial): in patients without loss of BRG-associated factor 250a (BAF250a) expression and in patients with loss of BAF250a expression.

SECONDARY OBJECTIVES:

I. To examine the nature and degree of toxicity in this patient population treated with this regimen in patients with and without loss of BAF250a expression.

II. To examine the progression-free survival and overall survival for this patient population receiving dasatinib in patients with and without loss of BAF250a expression.

TERTIARY OBJECTIVES:

I. To examine the agreement between BAF250a immunohistochemistry and AT rich interactive domain 1A (SWI-like) (ARID1A) mutation status using next generation sequencing performed in formalin-fixed, paraffin-embedded tumor tissue.

OUTLINE:

Patients receive dasatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Proportion of patients with objective tumor response rate (complete response [CR] or partial response [PR]) using RECIST version 1.1 [ Time Frame: Up to 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Duration of overall survival (OS) [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years ]
  OS will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
• Duration of progression-free survival (PFS) [ Time Frame: Duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ]
  PFS will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
• Incidence of adverse effects as assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]
  The frequency and severity of all toxicities are tabulated.

Original Secondary Outcome:

• Duration of progression-free survival (PFS) [ Time Frame: Duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years ]
  PFS will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
• Duration of overall survival (OS) [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years ]
  OS will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
• Frequency and severity of adverse effects as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 years ]
  The frequency and severity of all toxicities are tabulated.

Information By: National Cancer Institute (NCI)

Dates:
Date Received: February 7, 2014
Date Started: February 2014
Date Completion:
Last Updated: May 4, 2017
Last Verified: March 2017