Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma
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|ClinicalTrials.gov Identifier: NCT00003008|
Recruitment Status : Completed
First Posted : July 11, 2003
Last Update Posted : January 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: indinavir sulfate Drug: nelfinavir mesylate Drug: paclitaxel Drug: ritonavir Drug: saquinavir mesylate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Official Title:||Pilot Study to Evaluate the Potential Interactions Between Paclitaxel and Protease Inhibitors in Patients With AIDS-Related Kaposi's Sarcoma|
|Study Start Date :||June 1997|
|Actual Primary Completion Date :||June 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003008
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|Study Chair:||Jamie Hayden Von Roenn, MD||Robert H. Lurie Cancer Center|