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

Primary Purpose

Sarcoma

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
sorafenib tosylate
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult angiosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre Oscar LambretRecruiting

Outcomes

Primary Outcome Measures

Rate of non-progression at 9 months by RECIST criteria

Secondary Outcome Measures

Full Information

First Posted
April 2, 2009
Last Updated
December 23, 2009
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT00874874
Brief Title
Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Oscar Lambret

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult angiosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Primary Outcome Measure Information:
Title
Rate of non-progression at 9 months by RECIST criteria

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Penel, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Penel, MD
Phone
33-3-20-295-920

12. IPD Sharing Statement

Citations:
PubMed Identifier
24218035
Citation
Penel N, Ray-Coquard I, Bal-Mahieu C, Chevreau C, Le Cesne A, Italiano A, Bompas E, Clisant S, Baldeyrou B, Lansiaux A, Robin YM, Bay JO, Piperno-Neumann S, Blay JY, Fournier C. Low level of baseline circulating VEGF-A is associated with better outcome in patients with vascular sarcomas receiving sorafenib: an ancillary study from a phase II trial. Target Oncol. 2014 Sep;9(3):273-7. doi: 10.1007/s11523-013-0299-0. Epub 2013 Nov 12.
Results Reference
derived
PubMed Identifier
24005614
Citation
Valentin T, Fournier C, Penel N, Bompas E, Chaigneau L, Isambert N, Chevreau C. Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO). Invest New Drugs. 2013 Dec;31(6):1626-7. doi: 10.1007/s10637-013-0023-z. Epub 2013 Sep 5.
Results Reference
derived
PubMed Identifier
22285963
Citation
Ray-Coquard I, Italiano A, Bompas E, Le Cesne A, Robin YM, Chevreau C, Bay JO, Bousquet G, Piperno-Neumann S, Isambert N, Lemaitre L, Fournier C, Gauthier E, Collard O, Cupissol D, Clisant S, Blay JY, Penel N; French Sarcoma Group (GSF/GETO). Sorafenib for patients with advanced angiosarcoma: a phase II Trial from the French Sarcoma Group (GSF/GETO). Oncologist. 2012;17(2):260-6. doi: 10.1634/theoncologist.2011-0237. Epub 2012 Jan 27.
Results Reference
derived

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

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