Spots Global Cancer Trial Database for Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma

Study Description

Brief Summary: 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.

Detailed Description: 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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