Paclitaxel in Treating Older Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00003092|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 14, 2016
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients who have solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: paclitaxel||Phase 3|
- Determine whether there is a relationship between pharmacokinetic measurements of paclitaxel and aging.
- Determine whether there is a relationship between the toxic effects of paclitaxel and aging.
OUTLINE: Patients are stratified according to age (cohort 1: patients 55 to 64 vs cohort 2: patients 65 to 75 vs cohort 3: patients 75 and over).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Pharmacology of Paclitaxel in Relation to Patient Age|
|Study Start Date :||September 1997|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||June 2006|
Patients receive a single dose of IV paclitaxel over 3 hours. Additional cycles of paclitaxel will be given at the discretion of the physician.
Patients are followed for second malignancies, disease progression, and survival.
- Overall survival [ Time Frame: Up to 5 years ]
- Disease-free progression [ Time Frame: Up to 5 years ]
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): NCT00003092
Show 32 Study Locations
|Study Chair:||Stuart M. Lichtman, MD||Don Monti Comprehensive Cancer Center at North Shore University Hospital|