Dasatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma|
- 6-month progression-free survival (PFS) rate [ Designated as safety issue: No ]
- Objective tumor response rate (complete or partial response) [ Designated as safety issue: No ]
- Frequency and severity of adverse events as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]
- Duration of PFS and overall survival [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- To estimate the 6-month progression-free survival (PFS) rate and objective tumor response rate (complete or partial response) in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with dasatinib.
- To determine the frequency and severity of adverse events as assessed by CTCAE v3.0.
- To determine the duration of PFS and overall survival.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib once daily 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 every 3 months for 2 years and then every 6 months for 3 years.