Can a Blood-Flow-Blocking drug stall a rare sarcoma?
NCT ID NCT00874874
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing sorafenib, a drug that blocks enzymes tumors need to grow and cuts off their blood supply, in people with angiosarcoma that is locally advanced, has spread, or cannot be removed by surgery. The trial enrolls about 88 participants and measures how many remain free of disease progression after nine months. The goal is to see whether sorafenib can control this rare cancer when surgery is not an option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sorafenib, a drug that blocks enzymes tumors need to grow and cuts off their blood supply
- What this could lead to
- If it works, sorafenib could offer a way to slow or control angiosarcoma that surgeons cannot remove, giving patients more time without their disease worsening.
- What could go wrong
- This is a mid-stage trial in a rare cancer, so results may not hold up in larger studies. Sorafenib can cause side effects such as fatigue, skin reactions, high blood pressure, and liver problems, and not everyone will respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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88 people
The number who actually took part.
- Started
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May 2008
- Finished
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May 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU La Timone
Marseille, 13385, France
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Centre Antoine Lacassagne
Nice, 06189, France
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Centre François Baclesse
Caen, 14076, France
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Centre Georges François Leclerc
Dijon, 21079, France
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Centre Henri Becquerel
Rouen, 76038, France
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Centre Jean Perrin
Clermont-Ferrand, 63011, France
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Centre Léon Bérard
Lyon, 69008, France
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Centre Oscar Lambret
Lille, 59020, France
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Centre René Gauducheau
Saint-Herblain, 44805, France
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Centre Val d'Aurelle
Montpellier, 34298, France
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Groupe Hospitalier Cochin Cancer Ouest AP-HP
Paris, 75619, France
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Hôpital Jean Minjoz
Besançon, 25503, France
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Hôpital Saint-Louis
Paris, 75010, France
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Institut Bergonié
Bordeaux, 33076, France
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Institut Claudius Regaud
Toulouse, 31052, France
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Institut Curie
Paris, 75005, France
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Institut Paoli-Calmettes
Marseille, 13273, France
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Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270, France
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Other studies related to the condition(s) this trial covers.
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- Can a structured recovery plan speed healing after sarcoma surgery?