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

Inclusion Criteria:

* Histologically confirmed leiomyosarcoma of the uterus

  * Recurrent or persistent disease
  * Refractory to curative therapy or established treatments
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

  * Ascites and pleural effusions are not considered measurable disease
* Must have ≥ 1 target lesion to assess response

  * Tumors in a previously irradiated field are considered non-target lesions unless there is documented progression or biopsy-confirmed persistence ≥ 90 days after completion of radiotherapy
* Received at least 1 but no more than 2 prior cytotoxic regimens

  * Initial treatment may have included high-dose chemotherapy, consolidation, or extended therapy administered after surgery or nonsurgical assessment
  * Cytotoxic regimens may have included 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
* Not a candidate for a higher priority GOG protocol
* No known brain metastases
* GOG performance status 0-2 (for patients who have received 1 prior regimen) OR GOG 0-1 (for patients who have received 2 prior regimens)
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* SGOT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 1.5 times ULN
* QTc \< 500 msec
* LVEF normal by echocardiogram
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
* Patients with a pre-existing thyroid abnormality unable to maintain normal thyroid function with medication are not eligible
* 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