NCT00671788

A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the proportion of patients who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial) in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. SECONDARY OBJECTIVES: I. To determine the frequency and severity of adverse events as assessed by CTCAE v3.0. II. To determine the duration of progression-free survival and overall survival. TERTIARY OBJECTIVES: I. Objectives in formalin-fixed and paraffin-embedded (FFPE) tumor tissue before treatment with dasatinib. II. Explore the association between the expression and phosphorylation of biomarkers involved in Src signaling pathways and measures of clinical outcome as well as disease status. III. Bank residual FFPE tumor tissue for the development and characterization of predictive and/or prognostic biomarkers or the validation of thereapeutic targets. IV. Objectives in blood drawn before and/or during treatment with dasatinib. V. Isolate, enumerate and characterize circulating tumor cells (CTC) as well as circulating endothelial cells (CEC)/circulating endothelial precursors (CEP). VI. Prepare a buffy-coat specimen from residual blood remaining after isolation of CTC and CEC/CEP. VII. Explore whether CTC and CEC/CEP counts or characteristics are associated with measures of clinical outcome and disease status. VIII. Explore whether the expression and phosphorylation of biomarkers involved in Src signaling pathways in CTC and CEC/CEP are associated with measures of clinical outcome and disease status. IX. Explore the associations between germline single nucleotide polymorphisms (SNPs) in genes involved in drug metabolism, resistance and DNA repair and measures of clinical outcome and disease status. X. Bank residual DNA and buffy-coat specimens for the development and characterization of predictive and/or prognostic biomarkers or the validation of therapeutic targets. XI. Objectives in plasma prepared from blood drawn before and/or during treatment with dasatinib. XII. Explore the association between angiogenic markers and cytokines including VEGF and measures of clinical outcome and disease status. XIII. Explore the association between measures of cell-free DNA and measures of clinical outcome and disease status. XIV. Bank residual plasma for the development and characterization of predictive and/or prognostic biomarkers or the validation of therapeutic targets. 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.

Conditions

• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Dasatinib	Given orally
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-12-01
• First posted: 2008-05-05
• Last updated: 2016-04-15
• Results posted: 2014-07-18

Locations

20 sites across 1 country: United States