Clinical trial · Interventional
Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
Phase II Study, Multicenter, Randomized, Stratified, Evaluating the Efficacity of Weekly Paclitaxel, With or Without Bevacizumab in the Treatment of Metastatic or Locally Advanced Angiosarcomas Not Accessible to Surgery Treatment.
NCT01303497CI-TRIAL-00105442ANGIO-TAX+completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Angiosarcoma | Angiosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A : Paclitaxel
- description
- administration of paclitaxel drug during cycle of 28 days (6 cycles Max) + blood sample on day 1, 8, 15, 29 and 57
- interventionNames
- Drug: Paclitaxel
- type
- OTHER
- label
- Arm B : Paclitaxel + Bevacizumab
- description
- administration of paclitaxel drug during per cycle of 28 days (6 cycles Max) + Bevacizumab every two weeks during paclitaxel cycles then every 3 weeks during P cycles until disease progression or inacceptable toxicity \+ blood sample on day 1, 8, 15, 29 and 57
- interventionNames
- Drug: Paclitaxel
- Drug: Bevacizumab
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLebellec L, Bertucci F, Tresch-Bruneel E, Ray-Coquard I, Le Cesne A, Bompas E, Blay JY, Italiano A, Mir O, Ryckewaert T, Toiron Y, Camoin L, Goncalves A, Penel N, Le Deley MC. Prognostic and predictive factors for angiosarcoma patients receiving paclitaxel once weekly plus or minus bevacizumab: an ancillary study derived from a randomized clinical trial. BMC Cancer. 2018 Oct 11;18(1):963. doi: 10.1186/s12885-018-4828-1. PMID 30305054