Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma
OBJECTIVES:
- Determine whether the body distribution and plasma clearance of paclitaxel is affected
by protease inhibitors (e.g., indinavir, ritonavir, saquinavir mesylate, or nelfinavir
mesylate).
OUTLINE: Patients are stratified according to protease inhibitor treatment (yes vs no),
prior paclitaxel (yes vs no), and prior doxorubicin or daunorubicin (yes vs no).
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 2 weeks for
at least 1 course in the absence of disease progression or unacceptable toxicity. Patients
who previously received paclitaxel receive no more than 1 course during this study.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Jamie Hayden Von Roenn, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
CDR0000065583
NCT00003008
June 1997
Name | Location |
---|---|
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |