Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally A… (NCT01303497) | Clinical Trial Compass
CompletedPhase 2
Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
France70 participantsStarted 2010-09-10
Plain-language summary
Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…