- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00874874
Sorafenib in Treating Patients With Angiosarcoma That is Locally Advanced, Metastatic, or Unable to Be Removed by Surgery
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
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.
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Lille, France, 59020
- Recruiting
- Centre Oscar Lambret
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Contact:
- Nicolas Penel, MD
- Phone Number: 33-3-20-295-920
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rate of non-progression at 9 months by RECIST criteria
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000633547
- COL-Angio-Next
- BAYER-COL-Angio-Next
- COL-2007-10
- INCA-RECF0636
- EUDRACT-2007-004651-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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