Paclitaxel in Combination With Bevacizumab (Avastin«) for the Treatment of Metastatic or Unresectable Angiosarcoma
This is an open-label, single-arm, multi-center, Phase 2 study with Paclitaxel in combination with Bevacizumab in patients with Unresectable or Metastatic Angiosarcoma. The study aims to determine the safety and effectiveness of combining two drugs Paclitaxel and Bevacizumab in the treatment of Angiosarcoma that cannot be removed by surgery, or has spread to other parts of your body. The primary objective is to evaluate 4month non progression rate. The secondary objective is to evaluate overall response rate after 3rd and 6th cycle, median duration of response, 6th and 12th month survival, toxicity of Paclitaxel and Bevacizumab combination, toxicity of maintenance Bevacizumab and to collect paraffin-embedded tumor blocks for angiogenesis markers and tissue microarray.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Paclitaxel in combination with Bevacizumab
Phase: Phase 2
Ages Eligible For Study:
- Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study. Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging. - Patient must have at least one objective measurable disease parameter by RECIST criteria. - Patients must have unresectable locally advanced or metastatic angiosarcoma. - Patients must have had <= 2 prior chemotherapeutic regimens for angiosarcoma. - No prior paclitaxel, docetaxel, or bevacizumab for angiosarcoma. (Previous paclitaxel or docetaxel allowed if not given for angiosarcoma and more than 12 months has elapsed since last dose) - Patients must not have had evidence of other active malignancies other than carcinomas in-situ of the cervix or basal cell carcinoma of the skin within 6 months prior to registration. - Patients with a history of deep venous thrombosis or pulmonary embolism must be receiving a stable dose of anticoagulation therapy for at least 2 weeks prior to registration. - Patients must not have been using any anti-platelet drugs, such as ticlopidine, clopidogrel, and cilostazol, during study or within 7 days prior to registration. The use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAID) is allowed. - Patients must have an ECOG performance status 0-2. - Patients must have adequate organ function as evidenced by the following laboratory studies (within 2 weeks prior to registration): - Serum creatinine (<= 2.0 mg/dl) - Total bilirubin <= 2.0 x ULN and SGOT (AST) < 2 x ULN. If documented hepatic involvement, total bilirubin can be <= 3 x ULN, and AST <= 5 x ULN. - Absolute neutrophil count >= 1500/mm3 and platelet count > 100,000/mm3. - PT, INR, and PTT <= 1.5 x normal. - Patients must not have an active infection requiring parental antibiotics. - Patients must not have known HIV infection due to increase risk of infection. - Patients must have a left ventricular ejection fraction >= 50% to be eligible. - Patients must be age >= 13 years. - Women must not be pregnant or breast feeding due to potential harmful effects to the fetus/baby. Women of childbearing potential must have an HCG within 2 weeks prior to registration. - Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception.