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Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00330421 |
RATIONALE: Sorafenib may stop the growth of soft tissue sarcoma by blocking blood flow to the tumor and blocking some of the enzymes needed for tumor cell growth.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with soft tissue sarcoma.
Condition | Intervention | Phase |
Sarcoma |
Drug: sorafenib tosylate Procedure: conventional surgery |
Phase II |
MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
ChemIDplus related topics: | Sorafenib Sorafenib tosylate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Clinical and Correlative Study of BAY43-9006 (Sorafenib) IND 69,896 in Sarcoma |
Estimated Enrollment: | 20 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Group I: Experimental
Patients receive oral sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on approximately day 15. Once patients recover from surgery (and radiotherapy if indicated), patients who demonstrate a clinically and pathologically significant response (≥ 25% reduction in tumor size or ≥ 25% necrosis in the surgical specimen) may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator. Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure (IFP) is measured at baseline and immediately before surgery.
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Drug: sorafenib tosylate
Given orally
Procedure: conventional surgery
Patients undergo surgical resection of the tumor on day 15
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Group II: Experimental
Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.
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Drug: sorafenib tosylate
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are assigned to one of two groups (group 1 closed to accrual as of 5/30/07).
In both groups, blood samples are drawn periodically for pharmacological studies.
After completion of study therapy, patients are followed monthly until all study-related toxicities are resolved and then at the discretion of the investigator.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of bone or soft tissue sarcoma, meeting 1 of the following criteria:
Extremity sarcoma for which surgery is planned (closed for accrual as of 5/30/07)
Metastatic or inoperable sarcoma for which no known curative or survival-prolonging palliative therapy exists OR these therapies have failed
Treated and/or stable, asymptomatic brain metastasis allowed
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 3 weeks since prior and no concurrent radiotherapy
Concurrent warfarin anticoagulation therapy allowed provided all of the following criteria are met:
United States, Massachusetts | |||||
Beth Israel Deaconess Medical Center | |||||
Boston, Massachusetts, United States, 02215 | |||||
Dana-Farber/Brigham and Women's Cancer Center | |||||
Boston, Massachusetts, United States, 02115 | |||||
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |||||
Boston, Massachusetts, United States, 02115 | |||||
Massachusetts General Hospital | |||||
Boston, Massachusetts, United States, 02114 |
Dana-Farber Cancer Institute |
National Cancer Institute (NCI) |
Principal Investigator: | Jeffrey A. Morgan, MD | Dana-Farber Cancer Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000466187, DFCI-05033, NCI-6948 |
First Received: | May 25, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00330421 |
Health Authority: | United States: Food and Drug Administration |
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