Paclitaxel in Treating Older Patients With Solid Tumors
NCT ID: NCT00003092
Last Updated: 2016-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
1997-09-30
2006-06-30
Brief Summary
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PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients who have solid tumors.
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Detailed Description
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* 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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
paclitaxel
Interventions
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paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
55 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Stuart M. Lichtman, MD
Role: STUDY_CHAIR
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Locations
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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 D.C., 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
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Vermont Cancer Center
Burlington, Vermont, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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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.
Other Identifiers
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CLB-9762
Identifier Type: -
Identifier Source: secondary_id
CDR0000065800
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-9762
Identifier Type: -
Identifier Source: org_study_id
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