NCT01071928

Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma

A Phase II Trial of Docetaxel Plus ASA404 as Second-Line Therapy in Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU09-144

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1
DRUG	ASA404	ASA404 (given after Docetaxel)IV 1800 mg/m2 over approximately 20 minutes on Day 1

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-02-19
• Last updated: 2015-08-19