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

Phase 2
Completed
Conditions
Sarcoma
Registration Number
NCT00003008
Lead Sponsor
Eastern Cooperative Oncology Group
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
33
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Alabama at Birmingham Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

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