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Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma

2014-08-27 03:15:48 | BioPortfolio

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.

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Urothelial Carcinoma

Intervention

Docetaxel, ASA404

Location

Indiana University Melvin & Bren Simon Cancer Center
Indianapolis
Indiana
United States
46202

Status

Not yet recruiting

Source

Hoosier Oncology Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:48-0400

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Medical and Biotech [MESH] Definitions

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