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Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas - Article


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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

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00217620

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

Further Study Details: 

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

Endocrine therapy

  • Not specified

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00217620


Study chairs or principal investigators

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

Study ID Numbers:  CDR0000442404; SWOG-S0505
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



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December 1, 2008



Page Updated: September 6, 2005
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