Spots Global Cancer Trial Database for Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma

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Trial Identification

Brief Title: Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma

Official Title: Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma

Study ID: NCT00003008

Conditions

Sarcoma

Interventions

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with AIDS-related Kaposi's sarcoma.

Detailed Description: 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.