New hope for rare cancer: drug combo shows promise in advanced angiosarcoma
NCT ID NCT01303497
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding a targeted drug called bevacizumab to standard chemotherapy (paclitaxel) helps control advanced angiosarcoma, a rare cancer of blood vessels. About 70 adults whose cancer had spread or could not be removed by surgery took part. The goal was to see if the combination could stop the cancer from growing for at least 6 months.
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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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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2010
- Finished
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Jan 2019
- 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
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18 years and older
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Angiosarcoma histologically proven * Metastatic or locally advanced and not accessible to surgery treatment * Measurable tumor with at least 1 measurable lesion, according to RECIST * For angiosarcoma in irradiated region, absence of clinical arguments of progression of the tumor prior treated by radiation * At least 28 days since the previous treatment (systemic or major surgery) * Performance Status (ECOG) ≤ 1 * Man or woman \>= 18 years * Polynuclear neutrophils \>1500/mm3, platelets \> 100 000/ mm3, Hemoglobin \> 9.0 g/dl * Total bilirubin ≤ 1.5 x USL, AST and ALT ≤ 2.5 x USL (or ≤ 5 if hepatic metastasis ) * Serum creatinin ≤ 1.5 x USL or clearance calculated \> 50 ml/mn (Cockcroft formulae) * Absence of hematuria on dipstick * Proteinuria on dipstick \<2+, if \>2, the 24 hours proteinuria must be \< 1g * Albumin \> 35 g/l and lymphocytes \> 700/mm3 attesting a life expectancy \> 3 months * Normal cardiac function : LVEF ≥ 50% * Normal coagulation test : INR ≤ 1.5 and TCA ≤ 1.5 x USL within 7 days before inclusion * Systolic BP ≤ 150 mmHg and diastolic BP ≤ 100 mmHg * Negative pregnancy test for women of reproductive potential(within 7 days before treatment start) * Effective contraceptive methods for male and female (if applicable) during the period of treatment and until the 6 months after the last administration of Bevacizumab * Adequate central veinous access * Patient covered by government health insurance * Informed consent form signed by the patient Exclusion Criteria: * Patients that have received more than 2 regimens of chemotherapy whatever the indication * Kaposi's sarcoma, hemangio-endothelioma, hemangio-pericytoma (Malignant solitary fibrous tumor) * Surgery (except the diagnostic biopsy) or radiotherapy within the past 4 weeks before inclusion, except antalgic radiotherapy * Uncontrolled, active peptic ulcer, * Other malignant evolutive tumor * Previous thrombotic or hemorrhagic disorders * Clinically significant cardiovascular disease (stroke within 6 months prior inclusion, unstable angina, heart failure, myocardial infarction, arrhythmia requiring treatment) * Anticoagulant treatment for curative aim within 10 days before beginning of treatment (oral or parenteral administration), aspirin \> 325 mg/day, or Plavix or a thrombolytic (thrombolytics for preventive use is permitted) or anti-platelet (dipyridamol, ticlopidine, clodiprogel, cilostazol) * Chronic treatment(more than 15 days) by every AINS including aspirin \> 325 mg/j * Currently active bacterial or fungus infection (grade \> 2 CTCAE v4.02) * Known HIV1, HIV2, hepatitis B or hepatitis C infections * Presence of known meningeal or brain metastasis * Epilepsy requiring the use of anti-epileptic * Previous organ transplant * Peripheral stem cell transplantation within 4 months prior to inclusion in the study * Using of drugs affecting the biological response, for example G-CSF, within the 3 weeks before inclusion * Kidney dialysis patient * Clinically significant neuropathy (grade\> 2 CTCAE V4.02) * Any circumstance that could jeopardise compliance or proper follow-up during the trial * Pregnant or nursing women. Women should not breastfeed for at least 6 months after the last administration of Bevacizumab * Constitutional or acquired coagulopathy * Uncontrolled hypertension (SBP\> 150 mmHg or DBP\> 100 mmHg) * Known hypersensitivity to paclitaxel or to one of its excipients (Cremophor EL, to Bevacizumab components, to products of Chinese hamster ovary cells (CHO) or other recombinant human or humanized antibodies * Patients unable to undergo trail medical follow-up for geographical, social or psychological reasons * Patient refusal of ambulatory care
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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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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 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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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 Gustave Roussy
Villejuif, 94805, France
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Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New combo therapy aims to shrink sarcomas
- New Two-Drug immune attack launched against tough cancers
- New cocktail aims to shrink sarcomas: bevacizumab joins chemo in phase 2 trial
- New hope for rare cancers: immunotherapy drug targets tumors regardless of origin
- New hope for rare cancers? drug combo shows promise in early trial