Conditions: Sarcoma Leiomyosarcoma Malignant Fibrous Histiocytoma Angiosarcoma
Keywords: Bevacizumab (avastin) Gemcitabine Taxotere (docetaxel) 09-015 Soft tissue
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 47
Healthy volunteers: no

Brief summary:
The purpose of this study is to test whether an experimental drug called bevacizumab given together with gemcitabine and docetaxel, a standard chemotherapy regimen for sarcoma, can help sarcoma patients. This trial will examine what effects, good and/or bad the combination of gemcitabine, docetaxel and bevacizumab has on sarcoma.

Detailed description:

Arms:
arm 1: Patients will receive bevacizumab at 15 mg/kg on day 1 of each 21-day cycle intravenously over 30 minutes followed by a one hour (+30/-15 min) break. For cycles 1 through 6, gemcitabine will be administered at 900 mg/m2 over 90 minutes on day 1 and 8 of a 21-day cycle. Docetaxel will be administered at 75 mg/m2, over 60 minutes, on day 8. This will be followed by either 5 days of filgrastim or a single injection of pegfilgrastim. For cycles 7 and beyond, gemcitabine will be given at 800 mg/m2 over 30 minutes on day 1 and 8; docetaxel will be given at 35 mg/m2 over 30 minutes, also on days 1 and 8.

Interventions: intervention 1: gemcitabine intervention 2: docetaxel intervention 3: bevacizumab
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: