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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00874874
First received: April 2, 2009
Last updated: December 23, 2009
Last verified: July 2009
  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 angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.


Condition Intervention Phase
Sarcoma
Drug: sorafenib tosylate
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of non-progression at 9 months by RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: May 2008
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874874

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

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00874874     History of Changes
Other Study ID Numbers: CDR0000633547, COL-Angio-Next, BAYER-COL-Angio-Next, COL-2007-10, INCA-RECF0636, EUDRACT-2007-004651-10
Study First Received: April 2, 2009
Last Updated: December 23, 2009
Health Authority: Unspecified

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:
Hemangiosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014