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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00217620 |
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with advanced soft tissue sarcomas.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas |
Estimated Enrollment: | 75 |
Study Start Date: | March 2006 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to histology (leiomyosarcoma vs liposarcoma vs angiosarcoma, hemangiosarcoma, or hemangiopericytoma).
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 6 months for 2 years and annually for up to 3 years.
PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per stratum) will be accrued for this study within 15-38 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma of 1 of the following histologies:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
At least 28 days since prior radiotherapy and recovered
Surgery
Other
No concurrent administration of any of the following medications:
Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:
Study Chair: | Margaret von Mehren, MD | Fox Chase Cancer Center |
Investigator: | George D. Demetri, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000442404, SWOG-S0505 |
Study First Received: | September 20, 2005 |
Last Updated: | June 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00217620 |
Health Authority: | United States: Federal Government |
adult angiosarcoma adult leiomyosarcoma adult liposarcoma adult malignant hemangiopericytoma |
recurrent adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma |
Neoplasms, Connective and Soft Tissue Liposarcoma Leiomyosarcoma Malignant mesenchymal tumor Sarcoma |
Hemangiosarcoma Sorafenib Hemangiopericytoma Soft tissue sarcomas Recurrence |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |