Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma (NCT00245102) | Clinical Trial Compass
CompletedPhase 2
Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma
United States147 participantsStarted 2005-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sorafe…
What they're measuring
1
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST