Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed connective tissue neoplasm, including any of the following neoplastic subtypes:

Vascular connective tissue neoplasms
Leiomyosarcoma
Dermatofibrosarcoma protuberans
Chordoma
Desmoid tumors
High-grade undifferentiated pleomorphic sarcoma (e.g., malignant fibrous histiocytoma [including myxofibrosarcoma])
Carcinosarcomas (e.g., malignant mixed Müllerian tumors)
Giant hemangiomata
Kaposi sarcoma
Metastatic, locally advanced, or locally recurrent disease

Measurable disease

Tumor lesions in a previously irradiated area may be considered measurable provided there is evidence of growth that cannot be attributed to necrosis or bleeding
No gastrointestinal stromal tumor sarcomas

Prior standard neoadjuvant or adjuvant systemic therapy required for patients with the following diagnoses:

Rhabdomyosarcoma
Osteosarcoma
Ewing sarcoma
No untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as documented on screening CT scan or MRI

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 1.5 mg/dL
PT and INR ≤ 1.5
AST and ALT ≤ 2.5 times upper limit of normal
Creatinine ≤ 1.5 mg/dL
Calcium ≤ 12 mg/dL
Blood glucose < 150 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception prior to, during, and for 28 days after completion of study therapy
Other malignancies allowed provided sarcoma is the primary disease requiring systemic therapy
Able to swallow oral medications

No other disease or illness within the past 6 months, including any of the following:

Myocardial infarction
Severe or unstable angina
Coronary or peripheral artery bypass graft
Symptomatic congestive heart failure
Cerebrovascular accident or transient ischemic attack
Pulmonary embolism
No evidence of a bleeding diathesis
No ongoing cardiac dysrhythmias > grade 2
No uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg despite optimal medical therapy
Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan
No psychiatric illness or social situation that would preclude study compliance
No pre-existing thyroid abnormality, defined as abnormal thyroid function tests despite medication
No prolonged QTc interval (i.e., QTc > 450 msec for males or QTc > 470 msec for females) on baseline EKG
No hemorrhage ≥ grade 3 in the past 4 weeks

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior therapy
No prior sunitinib malate

No more than 3 prior cytotoxic chemotherapy regimens for metastatic disease

Adjuvant chemotherapy for sarcoma completed > 1 year prior to study entry is not considered a line of prior treatment
At least 2 weeks since prior cytotoxic chemotherapy
At least 6 weeks since prior carmustine or mitomycin C
At least 1 week since prior biological therapy or small molecule kinase inhibitors

At least 3 weeks since prior radiotherapy (except for palliative radiotherapy to specific sites)

Prior palliative radiotherapy allowed provided it is considered medically necessary and there are other target lesions to assess
More than 4 weeks since prior major surgery
Concurrent major surgery allowed provided study drug is stopped 2 weeks before surgery and resumed 2 weeks after surgery
Concurrent palliative radiotherapy (e.g., focal radiotherapy to a bony metastasis for relieving bone pain) allowed
No other concurrent investigational drugs
No concurrent participation in another clinical trial

No concurrent therapeutic anticoagulation (e.g., warfarin)

Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices allowed provided requirements for PT and INR are met

No other concurrent approved or investigational anticancer agents or treatment, including chemotherapy, biological response modifier therapy, hormonal therapy, or immunotherapy

Concurrent hormone replacement therapy for adrenal insufficiency allowed
No concurrent antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
No concurrent rifampin, theophylline, ketoconazole, or Hypericum perforatum (St. John's wort)