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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

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

NCT ID

NCT00874874

First Posted

April 2, 2009

Last Updated

December 23, 2009

Sponsor

Centre Oscar Lambret

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

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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