MedPath

Paclitaxel in Treating Older Patients With Solid Tumors

Phase 3
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Registration Number
NCT00003092
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
PaclitaxelpaclitaxelPatients 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.
Primary Outcome Measures
NameTimeMethod
Overall survivalUp to 5 years
Disease-free progressionUp to 5 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (32)

Rebecca and John Moores UCSD Cancer Center

🇺🇸

La Jolla, California, United States

UCSF Cancer Center and Cancer Research Institute

🇺🇸

San Francisco, California, United States

CCOP - Christiana Care Health Services

🇺🇸

Wilmington, Delaware, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

CCOP - Mount Sinai Medical Center

🇺🇸

Miami Beach, Florida, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Holden Comprehensive Cancer Center

🇺🇸

Iowa City, Iowa, United States

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

🇺🇸

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center - University Campus

🇺🇸

Worcester, Massachusetts, United States

Scroll for more (22 remaining)
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.