Paclitaxel, Carboplatin, and Galunisertib in Treating Patients with Newly Diagnosed, Persistent, or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Carcinosarcoma

Inclusion Criteria

• Women with a diagnosis of primary, recurrent or progressive uterine, ovarian, fallopian tube or peritoneal carcinosarcoma, for whom treatment with combination paclitaxel and carboplatin is recommended
• Written informed consent/assent prior to any study-specific procedures
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Tissue available for translational study
• Absolute neutrophil count (ANC) >= 1500 cells/mcl
• Platelets >= 100,000/mcl
• Creatinine =< 2.0 x upper limit of normal (ULN)
• Bilirubin =< 1.5 times institutional normal
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels =< 2.5 x ULN
• No disease-modifying therapy, including investigational treatments, within 28 days prior to initiation of study treatment
• Ability to swallow tablets
• For women of child-bearing potential: * Willingness to use a highly effective method of contraception during the study and for 6 months following the last dose of galunisertib. Negative beta human chorionic gonadotropin pregnancy test documented within 7 days prior to initiation of study drug
• Patient must have measurable disease before the treatment

Exclusion Criteria

• Planned radiotherapy during or after the study chemotherapy prior to disease progression
• Receipt of chemotherapy or radiation within 28 days of study treatment
• Have had a major surgical procedure or a significant traumatic injury within 28 days prior to study treatment; Minor procedures such as biopsy within 7 days prior to study treatment are allowed
• Active infection that would preclude receipt of chemotherapy
• Moderate or severe cardiovascular disease with one of the following: * Myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association class III/IV congestive heart failure, or uncontrolled hypertension * Major electrocardiography (ECG) abnormalities (e.g. Q-QS wave abnormalities, left ventricular hypertrophy, Wolff-Parkinson-White syndrome, complete bundle branch block, intraventricular block, atrial fibrillation, atrial flutter or major ST-T changes) not responding to medical treatments. Major abnormalities documented by echocardiogram (ECHO) with Doppler (for example, moderate or severe heart valve function defect) that is not stable for at least 6 months. Note: Left ventricular [LV] ejection fraction < 50% is allowed only if clinically stable for at least 6 months (evaluation based on the institutional lower limit of normal) * Predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan-syndrome, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computed tomography [CT] scan/magnetic resonance imaging [MRI] with contrast)
• Active pregnancy or lactation
• Second primary malignancy for which treatment during the study period would be recommended if this cancer were not also present
• Prior malignancy requiring treatment within the last 3 years
• Use of another investigational product or device within 4 weeks of study entry or during study participation