A Phase II Trial of Docetaxel Plus ASA404 as Second-Line Therapy in Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU09-144
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
12 months
No
Matthew Galsky, M.D.
Study Chair
Hoosier Oncology Group
United States: Food and Drug Administration
GU09-144
NCT01071928
June 2010
March 2013
Name | Location |
---|---|
Medical Consultants, P.C. | Muncie, Indiana 47303 |
Indiana University Melvin & Bren Simon Cancer Center | Indianapolis, Indiana 46202 |