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

Inclusion Criteria

• •Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
• •All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT
• •Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• •Patients must not be eligible for a higher priority GOG protocol, if one exists; in general, this would refer to any active GOG Phase III protocol for the same patient population
• •Patients who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2; patients who have received two prior regimens must have a GOG Performance Status of 0 or 1
• •Recovery from effects of recent surgery, radiotherapy, or chemotherapy
• •* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI).
• •* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
• •* Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration; six weeks for patient previously treated with monoclonal antibodies
• •Prior therapy
• •* Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment
• •* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
• •* Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
• •* Note: patients on this non-cytotoxic study are allowed to receive additional cytotoxic chemotherapy for management of recurrent or persistent disease, as defined above
• •* Patients must have NOT received any non-cytotoxic therapy for management of recurrent or persistent disease; patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen
• •* Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy
• •Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to CTCAE v 3.0 grade 1
• •Platelets greater than or equal to 100,000/mcl
• •Hemoglobin greater than or equal to 10 g/dL
• •Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1
• •Bilirubin less than or equal to 1.5 x ULN, CTCAE v3.0 grade 1
• •SGOT and alkaline phosphatase less than or equal to 2.5 x ULN, CTCAE v3.0 grade 1
• •Mg++, CA++, phosphate, K+, Na corrected to WNL
• •PT/INR, PTT less than or equal to 1 - 1.5 x ULN, CTCAE v 3.0 grade 1 except for patients on therapeutic anticoagulation
• •Neuropathy (sensory and motor) less than or equal to CTCAE v 3.0 grade 1
• •QTc interval on electrocardiogram must be less than or equal to 450 msec
• •Patients must have signed an approved informed consent and authorization permitting release of personal health information
• •Patients must meet pre-entry requirements as specified in section 7.0
• •Patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least 4 weeks following completion of protocol therapy
• •Patients must not be receiving any other investigational agent
• •Patients must be able to swallow whole pills