Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma

Completed · Phase 2

Conditions studied: Adult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Leiomyosarcoma, Adult Malignant Fibrous Histiocytoma, Adult Neurofibrosarcoma, Adult Synovial Sarcoma, Ovarian Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Uterine Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Uterine Sarcoma, Stage IV Adult Soft Tissue Sarcoma, Stage IV Uterine Sarcoma, Uterine Carcinosarcoma, Uterine Leiomyosarcoma

In brief

This phase II trial is studying how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent sarcoma. Sorafenib 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.

Key facts

Study ID

NCT00245102

Run by

National Cancer Institute (NCI)

People needed

147

Starts

2005-09-01

Expected to finish

2011-03-01

Last updated by the study team

2014-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed sarcoma, including any of the following neoplastic subtypes:
• Giant hemangioma
• Angiosarcoma (including epithelioid hemangioendothelioma)
• Malignant peripheral nerve sheath tumor
• Leiomyosarcoma (closed to accrual as of 11/29/06)
• High-grade undifferentiated pleomorphic sarcoma (i.e., malignant fibrous histiocytoma [including myxofibrosarcoma]) (closed to accrual as of 11/29/06)
• Synovial sarcoma (closed to accrual as of 11/29/06)
• Carcinosarcoma (closed to accrual as of 11/29/06)
• Metastatic, locally advanced, or locally recurrent disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Lesions in a previously irradiated area may be considered measurable provided there is evidence of subsequent disease progression that cannot be attributed to necrosis or bleeding
• No gastrointestinal stromal tumor
• No known brain metastases
• Performance status - ECOG 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• No evidence of bleeding diathesis
• Bilirubin ≤ 1.5 mg/dL
• INR ≤ 1.5
• AST and ALT ≤ 2.5 times upper limit of normal
• Creatinine ≤ 1.5 mg/dL
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No uncontrolled hypertension

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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