COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00217620
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : November 1, 2012
Last Update Posted : May 15, 2014
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Sarcoma Drug: sorafenib Phase 2

Detailed Description:


  • 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.

OTHER OBJECTIVES (if funding permits):

  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
Study Start Date : March 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: sorafenib
Drug: sorafenib
800 mg per day, daily until progression
Other Name: BAY 43-9006

Primary Outcome Measures :
  1. Objective Response (Confirmed, Complete and Partial) [ Time Frame: Assessment performed every eight weeks until progression. ]
    Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.

Secondary Outcome Measures :
  1. Four-month Progression-free Survival Rate [ Time Frame: 0 - 4 months ]
  2. Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug [ Time Frame: Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration of protocol treatment. ]
    Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • 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


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • No history of thromboembolic disease
  • No uncontrolled hypertension


  • 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


Biologic therapy

  • Not specified


  • 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


  • 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


  • At least 28 days since prior major surgery and recovered


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00217620

Show Show 184 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Margaret von Mehren, MD Fox Chase Cancer Center
Study Chair: George D. Demetri, MD Dana-Farber Cancer Institute
Publications of Results:
Ryan CW, von Mehren M, Rankin CJ, et al.: Phase II intergroup study of sorafenib (S) in advanced soft tissue arcomas (STS): SWOG 0505. [Abstract] J Clin Oncol 26 (Suppl 15): A-10532, 2008.

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00217620    
Other Study ID Numbers: NCI-2012-03063
S0505 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
CDR0000442404 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 22, 2005    Key Record Dates
Results First Posted: November 1, 2012
Last Update Posted: May 15, 2014
Last Verified: January 2013
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action