- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003130
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES: I. Evaluate the relationships between body surface area (BSA) and toxic effects, BSA and pharmacokinetics, and pharmacokinetics and toxic effects in women with recurrent solid tumors who receive a fixed total dose of paclitaxel. II. Determine the toxic effects of paclitaxel in these patients. III. Assess the pharmacokinetics of paclitaxel in these patients.
OUTLINE: Patients 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.
PROJECTED ACCRUAL: A total of 50 patients will be accrued over 13 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92093-0658
- University of California San Diego 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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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago Health Sciences Center
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene & 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
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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, 68198-3330
- 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 Jersey
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Paterson, New Jersey, United States, 07503
- St. Joseph's Hospital and Medical 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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South Carolina
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Charleston, South Carolina, United States, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, United States, 38103
- University of Tennessee, Memphis Cancer Center
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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 recurrent adult solid tumors Must have measurable or evaluable disease No known bone marrow metastasis
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Women Performance Status: Zubrod 0-2 Life Expectancy: Not specified Hematopoietic: Absolute 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 Renal: Creatinine no greater than 1.5 times upper limit of normal Other: Concurrently active secondary malignancies are allowed
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior paclitaxel therapy No more than 1 prior chemotherapy regimen for metastatic disease At least 4 weeks since chemotherapy Greater than 6 weeks since nitrosoureas, melphalan, or mitomycin Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy No prior whole pelvic radiation Surgery: At least 4 weeks since major surgery
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 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.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Antonius A. Miller, MD, Wake Forest University Health Sciences
Publications and helpful links
General Publications
- 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.
- Miller AA, Rosner GL, Egorin MJ, et al.: Prospective evaluation of body surface area (BSA) as a determinant of paclitaxel pharmacokinetics/pharmacodynamics in women with solid tumors (CALGB 9763). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-500, 125, 2003.
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-9763
- U10CA031946 (U.S. NIH Grant/Contract)
- CDR0000065893 (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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