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Brief 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
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
Study ID: NCT00671788
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Washington University School of Medicine, Saint Louis, Missouri, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield, Springfield, Missouri, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Tulsa Cancer Institute, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Upstate Carolina CCOP, Spartanburg, South Carolina, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Name: Russell Schilder
Affiliation: Gynecologic Oncology Group
Role: PRINCIPAL_INVESTIGATOR