Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma
- Determine whether the body distribution and plasma clearance of paclitaxel is affected
by protease inhibitors (e.g., indinavir, ritonavir, saquinavir mesylate, or nelfinavir
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.
Primary Purpose: Treatment
Jamie Hayden Von Roenn, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|