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

NCT00874874 | Unknown Phase 2

• 6 other identifiers: CDR0000633547COL-Angio-NextBAYER-COL-Angio-NextCOL-2007-10INCA-RECF0636EUDRACT-2007-004651-10
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; adult angiosarcoma

Outcome Measures

Primary Outcomes (1)

• Rate of non-progression at 9 months by RECIST criteria

Interventions

sorafenib tosylate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 24218035 DERIVED

• 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.

  PMID: 24005614 DERIVED

• 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.

  PMID: 22285963 DERIVED

MeSH Terms

Conditions

Sarcoma; Hemangiosarcoma

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nicolas Penel, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Last Updated: December 24, 2009

Record last verified: 2009-07

Locations

FR (1)