Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

Exclusion Criteria

• •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, computed tomography (CT), and magnetic resonance imaging (MRI), or \>= 10 mm when measured by spiral CT; measurable disease lesions must be amenable to pre- and post- treatment biopsy
• •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 have a Gynecologic Oncology Group (GOG) performance status of 0 to 2
• •Recovery from effects of recent surgery, radiotherapy, or chemotherapy
• •Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
• •Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
• •Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
• •Patients should have had NO prior chemotherapy agents for advanced or recurrent endometrial cancer; prior chemotherapy administration in conjunction with primary radiation therapy as a radiosensitizer would not exclude a patient from participation in this trial
• •Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL, equivalent to Common Terminology Criteria (CTCAE version \[v\]4) grade 1
• •Platelets greater than or equal to 100,000/mcL
• •Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4 grade 1
• •Bilirubin less than or equal to 1.5 x ULN (CTCAE v4 grade 1)
• •Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 x ULN (CTCAE v4 grade 1)
• •Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4 grade 1)
• •Neuropathy (sensory and motor) less than or equal to CTCAE v4 grade 1
• •Therapeutic anticoagulation is not contraindicated, but for those patients on therapeutic anticoagulation, alteration in coagulation parameters is expected following initiation of dasatinib; for patients on therapeutic anticoagulation, coagulation parameters should be assessed weekly for the first cycle following initiation of dasatinib, weekly for the first cycle following a dose reduction, and weekly for a minimum of two weeks after stopping dasatinib
• •Warfarin is permitted for prophylaxis or treatment of thrombosis; Note: low-molecular weight heparin is permitted provided the patient's prothrombin time (PT)/international normalized ratio (INR) is =\< 1.5; for patients on anticoagulation, coagulation parameters should be assessed weekly for the first cycle following initiation of dasatinib, weekly for the first cycle following a dose reduction, and weekly for a minimum of two weeks after stopping dasatinib
• •Patients who have isolated recurrences (vaginal, pelvic, or para-aortic) that are amenable to potentially curative treatment with radiation therapy or surgery
• •Patients who have had a prior chemotherapy regimen for advanced or metastatic disease are excluded; patients who received adjuvant chemotherapy must be disease-free for at least 6 months
• •Patients may have received prior radiation therapy for treatment of endometrial carcinoma; prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy, alone or with chemotherapy as a radiation sensitizer; all radiation therapy must be completed at least 4 weeks prior to the first date of study therapy; the prior radiation field, radiation dose, number of fractions and prior radiation start and stop dates must be provided at registration
• •Patients who have previously received dasatinib; additionally, patients may not be receiving any other investigational agents; patients may have received prior hormonal therapy for treatment of endometrial carcinoma; all hormonal therapy must be discontinued at least one week prior to the first date of study therapy; patients with known brain metastases should be excluded from this clinical trial
• •Patients with serious, non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula or gastrointestinal perforation; patients with an intra-abdominal abscess within 28 days prior to the first date of dasatinib therapy are ineligible
• •Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels; patients who have a history of significant bleeding disorder unrelated to cancer including:
• •* Bleeding diathesis, congenital or acquired within one year prior to initiating protocol therapy (e.g. von Willebrand's disease, acquired anti-factor VIII antibodies); significant gastrointestinal (GI) bleeding within three months prior to initiating protocol therapy
• •Patients with history or evidence upon physical examination of central nervous system (CNS) disease (treated or untreated), including primary brain tumor, seizures not controlled with standard medical therapy, or any brain metastases
• •Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events (CTCAE v4 grade 2 or greater, excluding alopecia) due to agents administered more than 4 weeks earlier
• •Patients cannot take St. John's wort or drink grapefruit juice while on study treatment (discontinue St. John wort at least five days before starting dasatinib)
• •Patients who have an active pleural or pericardial effusion of any grade
• •Patients receiving IV bisphosphonates agree that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia, and may be restarted only if any hypocalcemia has been corrected
• •Patients with clinically significant cardiovascular disease; this includes:
• •* Uncontrolled hypertension, defined as systolic \> 140 mmHg or diastolic \> 90 mm Hg
• •* Myocardial infarction or unstable angina within 6 months of the first date of dasatinib therapy
• •* New York Heart Association (NYHA) class II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; this would include women with atrial fibrillation, who require rate-controlling medication
• •* CTCAE v4 grade 2 or greater peripheral vascular disease
• •* History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within six months of the first date of dasatinib therapy
• •* Patients with hypokalemia or hypomagnesemia if it cannot be corrected to within normal limits prior to dasatinib treatment
• •* Required use of a concomitant medication that can prolong the QT interval
• •Patients may not be receiving any prohibited potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors; for these drugs, a washout period of greater than or equal to 7 days is required prior to starting dasatinib treatment
• •The concomitant use of histamine (H2) blockers and proton pump inhibitors (PPI's) with dasatinib is not recommended (e.g., famotidine, omeprazole); the use of antacids should be considered in place of H2 blockers or PPIs in patients receiving dasatinib therapy; if antacid therapy is needed, the antacid dose should be administered two hours before or after the dose of dasatinib
• •Patients may not be receiving any other investigational agents
• •Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
• •Patients who are pregnant or nursing; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• •Uterine carcinosarcoma and other sarcomas of the uterus will be excluded