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Connective Tissue Disorders |
Connective Tissue Disease; Dupuytren's Contracture; Mixed Connective Tissue Disease; PXE |
Clinical Trial: Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) September 2005
Purpose
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 |
|---|---|---|
| adult soft tissue sarcoma | Drug: sorafenib Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy | Phase II |
MedlinePlus related topics: Soft Tissue Sarcoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Sorafenib in Patients With Advanced Soft Tissue Sarcomas
OBJECTIVES:
- Determine the objective response rate (confirmed, complete, and partial) in patients with advanced soft tissue sarcomas treated with sorafenib.
- Determine the 4-month progression-free survival rate in patients treated with this drug.
- Determine the frequency and severity of adverse events in patients treated with this drug.
- Correlate, preliminarily, a decrease in standard uptake variable (SUV) of target lesions by positron-emission tomography scan at 4 weeks with response in patients treated with this drug.
- Correlate, preliminarily, the phosphorylation status of KIT, PDGFR, VEGFR, and the raf/mek/erk pathway with response in patients treated with this drug.
- Correlate, preliminarily, the most common B-raf kinase mutation with response in patients treated with this drug.
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.
Eligibility
DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue sarcoma of 1 of the following histologies:
- Angiosarcoma, cutaneous or visceral
- Malignant hemangiosarcoma
- Malignant hemangiopericytoma
- Grade 3-4 leiomyosarcoma
- Grade 3-4 liposarcoma
- Must have evidence of unresectable residual disease, metastatic disease, or recurrent disease by radiography
- Measurable disease by x-ray, scans, or physical examination
- Archived paraffin-embedded tumor sections available
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
- Bilirubin normal (≤ 2.5 times ULN if due to liver metastases)
- PT, PTT, and INR normal
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- No history of thromboembolic disease
- No uncontrolled hypertension
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to swallow oral medication
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and recovered
- Prior adjuvant chemotherapy allowed
- No more than 1 prior chemotherapy regimen for metastatic disease
Endocrine therapy
- Not specified
Radiotherapy
- At least 28 days since prior radiotherapy and recovered
- Must have evidence of disease progression within, or measurable disease outside of, the radiation field after completion of radiotherapy
Surgery
- At least 28 days since prior major surgery and recovered
Other
- No prior sorafenib
- No prior inhibitor of VEGFR or MAPK pathway
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No concurrent therapeutic anticoagulation
- No concurrent administration of any of the following medications:
- Rifampin
- Hypericum perforatum (St. John''''s wort)
- Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:
- Phenytoin
- Carbamazepine
- Phenobarbital
Location and Contact Information
Margaret von Mehren, MD, Study Chair, Fox Chase Cancer Center
George D. Demetri, MD, Dana Farber Harvard Cancer Center
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: September 21, 2005
Record first received: September 20, 2005
ClinicalTrials.gov Identifier: NCT00217620
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-27
Resources
- Arthritis Foundation
- ClinicalTrials.gov: Connective Tissue Diseases (National Institutes of Health)

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