Paclitaxel in Treating Older Patients With Solid Tumors
Clinical Pharmacology of Paclitaxel in Relation to Patient Age
4 other identifiers
interventional
120
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 1997
Longer than P75 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJuly 14, 2016
July 1, 2016
8.5 years
November 1, 1999
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall survival
Up to 5 years
Disease-free progression
Up to 5 years
Study Arms (1)
Paclitaxel
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (32)
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021, United States
Mount Sinai Medical Center, NY
New York, New York, 10029, United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103, United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
Related Publications (2)
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.
PMID: 16567769RESULTLichtman 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.
RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stuart M. Lichtman, MD
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
September 1, 1997
Primary Completion
March 1, 2006
Study Completion
June 1, 2006
Last Updated
July 14, 2016
Record last verified: 2016-07