Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

Exclusion Criteria

• •No significant EKG abnormalities (i.e., no history of serious ventricular arrhythmia OR EKG with ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
• •No sensory or motor neuropathy \> grade 1
• •No NYHA class III-IV congestive heart failure
• •* NYHA class II cardiac dysfunction allowed
• •* History of NYHA class II heart failure that is asymptomatic on treatment allowed
• •No active infection requiring antibiotics
• •No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
• •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
• •No poorly controlled hypertension (i.e., systolic blood pressure \[BP\] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
• •No gastrointestinal tract disease resulting in an inability to take oral medication
• •No requirement for IV alimentation
• •No active peptic ulcer disease
• •No other condition that would impair ability to swallow and retain study drug
• •No serious or nonhealing wound, ulcer, or bone fracture
• •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• •No cerebrovascular accident or transient ischemic attack within the past year
• •No myocardial infarction, cardiac arrhythmia, stable or unstable angina, or symptomatic congestive heart failure within the past year
• •No pulmonary embolism within the past year
• •No uncontrolled illness including, but not limited to, any of the following:
• •* Ongoing or active infections
• •* Psychiatric illness or social situations that would preclude study compliance
• •Recovered from prior surgery, chemotherapy, or radiotherapy
• •Prior anthracycline exposure and central thoracic radiation that included the heart allowed provided patient has New York Heart Association (NYHA) class II cardiac function
• •At least 1 week since prior hormonal therapy
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) or radiotherapy
• •At least 4 weeks since prior major surgery
• •At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin and no recurrent or metastatic disease
• •At least 3 years since prior adjuvant chemotherapy for localized cancer of the breast and no recurrent or metastatic disease
• •No prior radiotherapy to any portion of the abdominal cavity or pelvis unless for treatment of leiomyosarcoma
• •No prior chemotherapy to any portion of the abdominal cavity or pelvis unless for treatment of leiomyosarcoma
• •No prior noncytotoxic chemotherapy for recurrent or persistent disease
• •No prior surgical procedures affecting absorption
• •No coronary or peripheral artery bypass graft or stenting within the past year
• •No other prior antiangiogenic agents (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, vatalanib, or vascular endothelial growth factor \[VEGF\] Trap)
• •No other prior cancer treatment that would preclude study treatment
• •At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
• •* Azole fungals (e.g., ketoconazole or itraconazole)
• •* Clarithromycin
• •* Erythromycin
• •* Diltiazem
• •* Verapamil
• •* HIV protease inhibitors (e.g., indinavir, saquinavir, ritonavir, atazanavir, or nelfinavir)
• •* Delavirdine
• •At least 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
• •* Rifampin
• •* Rifabutin
• •* Carbamazepine
• •* Phenobarbital
• •* Phenytoin
• •* Hypericum perforatum (St. John's wort)
• •* Efavirenz
• •* Tipranavir
• •No concurrent proarrhythmic potential agent, including any of the following:
• •* Terfenadine
• •* Quinidine
• •* Procainamide
• •* Disopyramide
• •* Sotalol
• •* Probucol
• •* Bepridil
• •* Haloperidol
• •* Risperidone
• •* Indapamide
• •* Flecainide
• •No concurrent therapeutic coumarin-derivative anticoagulants, such as warfarin
• •* Doses ≤ 2 mg daily allowed for prophylaxis of thrombosis
• •* Low molecular weight heparin allowed provided PT INR ≤ 1.5
• •No concurrent amifostine or other protective agents
• •No concurrent combination antiretroviral therapy for HIV-positive patients
• •No other concurrent investigational agents
• •No other concurrent anticancer agents or therapies