- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003092
Paclitaxel in Treating Older Patients With Solid Tumors
Clinical Pharmacology of Paclitaxel in Relation to Patient Age
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.
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
California
-
La Jolla, California, United States, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Florida
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center - University Campus
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198-7680
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, United States, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, United States, 38103
- University of Tennessee Cancer Institute
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Vermont
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Burlington, Vermont, United States, 05401-3498
- Vermont Cancer Center
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Virginia
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Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically proven nonhematologic malignancy
PATIENT CHARACTERISTICS:
Age:
- 55 and over
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- SGOT less than 2.0 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No uncontrolled or severe cardiovascular disease
Other:
- No serious intercurrent medical illnesses that in the judgement of the investigator compromise patient care
- No psychiatric conditions that would preclude study
- No requirement for antibiotics for active acute infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No more than one prior chemotherapy regimen allowed
- No prior paclitaxel allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiation therapy
Surgery:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paclitaxel
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Up to 5 years
|
Up to 5 years
|
Disease-free progression
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Lichtman SM, Hollis D, Miller AA, Rosner GL, Rhoades CA, Lester EP, Millard F, Byrd J, Cullinan SA, Rosen DM, Parise RA, Ratain MJ, Egorin MJ; Cancer and Leukemia Group B (CALGB 9762). Prospective evaluation of the relationship of patient age and paclitaxel clinical pharmacology: Cancer and Leukemia Group B (CALGB 9762). J Clin Oncol. 2006 Apr 20;24(12):1846-51. doi: 10.1200/JCO.2005.03.9289. Epub 2006 Mar 27.
- Lichtman SM, Egorin M, Rosner G, et al.: Clinical pharmacology of paclitaxel in relation to patient age: CALGB 9762. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A732, 1999.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CALGB-9762
- U10CA031946 (U.S. NIH Grant/Contract)
- CLB-9762
- CDR0000065800 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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