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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic, locally advanced, or locally recurrent sarcomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Dana-Farber Cancer Institute; National Cancer Institute (NCI)
• Treatments: Sunitinib

Criteria

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)