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 Hematopoietic: * 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 Hepatic: * Bilirubin \< 1.5 x ULN * Aspartate aminotransferase (AST, ALT) \< 2.5 x ULN Renal: * Calculated creatinine clearance of \> 45 cc/min using the Cockcroft-Gault formula Cardiovascular: * 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
To determine the best overall response rate (as measured by RECIST version 1.1) of docetaxel + ASA404 as second line therapy in patients with advanced urothelial carcinoma.
Time frame: 12 months
To evaluate progression-free survival in patients with advanced urothelial carcinoma
Time frame: 12 months
To evaluate survival at 1 year from start of treatment in patients with advanced urothelial carcinoma treated with docetaxel + ASA404 as second line therapy
Time frame: 12 months
To evaluate the safety of docetaxel and ASA404 combination, as measured by the NCI Common Toxicity Criteria version 3.0
Time frame: 12 months
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