Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01303497 : Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01303497      |      Link to official Clinicaltrials.gov listing
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