NCT00003008

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	indinavir sulfate
DRUG	nelfinavir mesylate
DRUG	paclitaxel
DRUG	ritonavir
DRUG	saquinavir mesylate

Timeline

• Start date: 1997-12-15
• Primary completion: 2006-06-01
• First posted: 2003-07-11
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States