Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas

• Status: Completed
• Trial end date: 2019-01-29
• Target enrollment: 0
• Participant gender: All

Summary

Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Collaborators: French Sarcoma Group; Groupe d’études des Tumeurs Osseuses; Groupe Sarcome Français; Study Group of Bone Tumors
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Paclitaxel

Criteria

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