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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00874874
Acronym
AngioNext
Enrollment
88
Registered
2009-04-03
Start date
2008-05-23
Completion date
2018-05-23
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

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

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.

Interventions

DRUGsorafenib tosylate

Sponsors

Centre Oscar Lambret
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frame
Rate of non-progression at 9 months by RECIST criteria

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNicolas Penel, MD, PhD

Centre Oscar Lambret

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026