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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given orally
Correlative studies
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
...and 10 more locations
Progression-free Survival at 6 Months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Time frame: Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Time frame: Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0
Time frame: Every cycle during treatment
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Time frame: Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Overall Survival
Time frame: Every other cycle up to 5 years
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