Paclitaxel in Treating Women With Recurrent Solid Tumors
Prospective Evaluation of Body Surface Area (BSA) as a Determinant of Paclitaxel Pharmacokinetics/Pharmacodynamics in Women With Solid Tumors
3 other identifiers
interventional
32
1 country
34
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women who have recurrent 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_2
Started Nov 1997
Longer than P75 for phase_2
34 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
November 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2002
CompletedFirst Posted
Study publicly available on registry
November 25, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJuly 19, 2016
July 1, 2016
4.2 years
November 1, 1999
July 15, 2016
Conditions
Keywords
Study Arms (1)
paclitaxel
EXPERIMENTALPatients receive single fixed dose intravenous paclitaxel over 3 hours on day 1. Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24 hours after the start of the infusion during course 1 only. Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients are evaluated for response after the second course. Patients are followed at the discretion of the physician.
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 (34)
University of California San Diego 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 Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009, United States
Marlene & 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
Worcester, Massachusetts, 01655, 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, 68198-3330, 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
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503, 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
Medical University of South Carolina
Charleston, South Carolina, 29425-0721, United States
University of Tennessee, Memphis Cancer Center
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 (1)
Miller AA, Rosner GL, Egorin MJ, Hollis D, Lichtman SM, Ratain MJ. Prospective evaluation of body surface area as a determinant of paclitaxel pharmacokinetics and pharmacodynamics in women with solid tumors: Cancer and Leukemia Group B Study 9763. Clin Cancer Res. 2004 Dec 15;10(24):8325-31. doi: 10.1158/1078-0432.CCR-04-1078.
PMID: 15623609RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Antonius A. Miller, MD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
November 25, 2003
Study Start
November 1, 1997
Primary Completion
January 1, 2002
Study Completion
January 1, 2006
Last Updated
July 19, 2016
Record last verified: 2016-07