Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery (NCT01623869) | Clinical Trial Compass
CompletedPhase 2
Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery
United States16 participantsStarted 2012-07
Plain-language summary
This phase II trial studies how well trebananib works in treating patients with advanced angiosarcoma that cannot be removed by surgery. Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically confirmed angiosarcoma that is unresectable
* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 2 cm with conventional techniques or as \>= 1 cm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
* Patients must have had =\< 4 prior systemic treatment regimens
* Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky \>= 70%
* Life expectancy of greater than 3 months
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Hemoglobin \>= 8.5g/dL
* Platelet count \>= 60,000/mcL
* Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 times institutional ULN
* Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase\[SGPT\]) =\< 2.5 times institutional ULN
* Partial thromboplastin time (PTT) or activated (a)PTT =\< 1.5 times ULN per institutional laboratory range
* International normalized ratio(INR) =\< 1.5 (unless on warfarin)
* Creatinine =\< 1.5 times ULN OR creatinine clearance \> 40 mL/min per 24-hour urine collection or calculated according to the Cockcroft-Gault formula
* Urinary protein =\< 3…