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Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery

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: NCT00874874
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : April 3, 2009
Last Update Posted : December 24, 2009
Information provided by:
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 angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.

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

Detailed Description:



  • Determine the rate of non-progression at 9 months in patients with unresectable, locally advanced, or metastatic angiosarcoma treated with sorafenib tosylate.


  • Determine the rate of non-progression at 60, 120, and 180 days.
  • Determine the median time to progression.
  • Determine overall survival.
  • Determine the best response rate.
  • Determine the clinical and biological factors that predict clinical benefit.
  • Evaluate tolerability by NCI CTCAE v3.0.
  • Correlate efficacy with plasma expression of genes implicated in controlling angiogenesis.
  • Explore the tumor expression of these genes in tissue from a tumor bank.

OUTLINE: This is a multicenter study.

Patients are stratified according to disease type (cutaneous angiosarcoma [scalp, breast, or soft tissue] vs visceral angiosarcoma). All patients receive oral sorafenib tosylate twice daily for 9 months in the absence of disease progression or unacceptable toxicity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery
Study Start Date : May 2008
Estimated Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Rate of non-progression at 9 months by RECIST criteria

Information from the National Library of Medicine

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


  • Histologically confirmed angiosarcoma

    • Locally advanced or metastatic disease
    • Unresectable disease
  • No Kaposi sarcoma, hemangiopericytoma, or hemangioendothelioma
  • Measurable tumor with at least 1 measurable lesion by RECIST criteria
  • Tumor in a previously irradiated area must not show progression
  • No brain metastases or meningeal tumors (symptomatic or asymptomatic)


  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • PT or INR and aPTT ≤ 1.5 times upper limit of normal (ULN)

    • Anticoagulation treatment with heparin or vitamin K allowed if the above criteria are met
  • Liver transaminases ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
  • Total bilirubin ≤ 1.5 times ULN
  • Serum creatinine ≤ 1.5 times ULN
  • Amylase and lipase ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Weight loss from pre-disease weight < 20% over the past 12 months
  • Able to swallow
  • No active or ischemic coronary artery disease
  • No myocardial infarction within the past 6 months
  • No NYHA class III-IV cardiac failure
  • No uncontrolled hypertension
  • No coagulopathy
  • No active uncontrolled peptic ulcer
  • No patients on renal dialysis
  • No active bacterial or fungal infection > CTCAE v3.0 grade 2
  • No HIV or hepatitis B or C positivity
  • No chronic unstable illness that could jeopardize patient safety or compliance
  • No other progressive or malignant tumor
  • No known or suspected allergy to sorafenib tosylate
  • No psychological, familial, social, or geographic situations that preclude clinical follow up
  • No patients deprived of liberty or under guardianship
  • No cardiac arrhythmia requiring antiarrhythmic medication (except beta-blockers or digoxin for chronic atrial fibrillation)
  • No epilepsy requiring antiepileptic drugs


  • See Patient Characteristics
  • No prior organ or peripheral stem cell transplantation
  • No more than 2 prior lines of chemotherapy
  • At least 28 days since prior treatment (systemic or major surgery)
  • No concurrent therapy for another malignancy
  • No concurrent CYP3A inducers (e.g., rifampicin, St. John wort, phenytoin, carbamazepine, phenobarbital, dexamethasone)

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): NCT00874874

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Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Nicolas Penel, MD    33-3-20-295-920      
Sponsors and Collaborators
Centre Oscar Lambret
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Principal Investigator: Nicolas Penel, MD Centre Oscar Lambret

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00874874    
Other Study ID Numbers: CDR0000633547
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
adult angiosarcoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action