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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• 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

• No history of allergic reaction to compounds of similar chemical or biologic composition to sorafenib

• No known HIV positivity

• No active or ongoing infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No psychiatric illness or social situation that would preclude study compliance

• No swallowing dysfunction that would preclude the swallowing of tablets

• Other malignancies allowed provided sarcoma is the primary disease requiring treatment

• No other uncontrolled illness

• No more than 1 prior chemotherapy regimen for recurrent or metastatic disease (≤ 3 regimens for angiosarcoma or malignant peripheral nerve sheath tumor)

• Adjuvant chemotherapy completed > 1 year prior to study entry is not considered a line of prior treatment

• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• At least 3 weeks since prior radiotherapy

• Recovered from prior antitumor therapy

• Alopecia allowed

• No prior sorafenib

• No prior small molecule inhibitors of MAPK signaling intermediates

• No concurrent therapeutic anticoagulation

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

• No other concurrent investigational agents

• No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)

• No concurrent rifampin or Hypericum perforatum (St. John's wort)