Paclitaxel in Treating Older Patients With Solid Tumors
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: paclitaxel||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Pharmacology of Paclitaxel in Relation to Patient Age|
- Overall survival [ Time Frame: Up to 5 years ]
- Disease-free progression [ Time Frame: Up to 5 years ]
|Study Start Date:||September 1997|
|Study Completion Date:||June 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003092
Show 32 Study Locations
|Study Chair:||Stuart M. Lichtman, MD||Don Monti Comprehensive Cancer Center at North Shore University Hospital|