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Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas
This study is ongoing, but not recruiting participants.
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
Sarcoma
Drug: sorafenib tosylate
Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as measured by RECIST every 8 weeks [ Designated as safety issue: No ]
  • Progression-free survival by RECIST every 8 weeks for 4 months [ Designated as safety issue: No ]
  • Adverse events by CTC v 3 continuously [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlation of positron-emission tomography (PET) scan and response as measured by a decrease in standard uptake variable (SUV) at baseline and 4 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: March 2006
Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217620

  Show 188 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Margaret von Mehren, MD Fox Chase Cancer Center
Investigator: George D. Demetri, MD Dana-Farber Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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.

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

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

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Liposarcoma
Leiomyosarcoma
Malignant mesenchymal tumor
Sarcoma
Hemangiosarcoma
Sorafenib
Hemangiopericytoma
Soft tissue sarcomas
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009