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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.