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The purpose of this study is to explore the safety and activity of docetaxel + ASA404 as second-line chemotherapy in patients with advanced urothelial carcinoma.
OUTLINE: This is a multi-center study.
21 Day Cycle Treatment Regimen:
- Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1
- ASA404 (given after Docetaxel) IV 1800 mg/m2 over approximately 20 minutes on Day 1
Treatment will continue until disease progression or intolerable treatment related adverse effects.
Karnofsky performance status of ≥ 70% within 7 days prior to registration for protocol therapy.
Life Expectancy: Not specified
- Hemoglobin (Hgb) > 9 g/dL
- Platelets > 100 K/mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
- INR or Prothrombin Time (PT) < 1.5 x ULN
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST, ALT) < 2.5 x ULN
- Calculated creatinine clearance of > 45 cc/min using the Cockcroft-Gault formula
- No congestive heart failure (NY Heart Association class III or IV)
- No myocardial infarction within 12 months of study registration for protocol therapy or with implanted cardiac pacemaker
- No unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Indiana University Melvin & Bren Simon Cancer Center
Not yet recruiting
Hoosier Oncology Group
Published on BioPortfolio: 2014-08-27T03:15:48-0400
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