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
PHASE2
109 participants
INTERVENTIONAL
1998-09-30
2008-01-31
Brief Summary
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PURPOSE: Phase II trial to compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors.
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Detailed Description
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* Compare the population pharmacokinetics of docetaxel in Caucasians and African American patients with solid tumors.
* Compare the pharmacodynamic effect of a single dose of docetaxel in relation to hematological toxicity in these patient populations.
* Determine the CYP3A4 genotype and P-glycoprotein (P-gp) expression and their relationship to docetaxel clearance in these patient populations.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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docetaxel
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1. Patients may receive additional courses beginning 21 days after the first docetaxel dose at the discretion of the physician.
docetaxel
Interventions
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docetaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically proven unresectable solid tumors (e.g., lung, breast, head and neck, bladder)
* Clinically suitable for treatment with single agent docetaxel
* Caucasian (at least 2 generations originating in any of the original peoples of Europe, North Africa, or the Middle East) OR
* African American (at least 2 generations originating in any of the black racial groups of Africa)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* 0-2
Hematopoietic:
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* AST no greater than 1.5 times ULN AND
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* BUN no greater than 1.5 times ULN
* Creatinine no greater 1.5 times ULN
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior bone marrow transplantation
Chemotherapy:
* No prior docetaxel
* Prior paclitaxel allowed
* 1 or 2 prior chemotherapy regimens allowed
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormones for disease related conditions
* Concurrent steroids for adrenal failure allowed
Radiotherapy:
* At least 2 weeks since prior radiotherapy
* Palliative radiotherapy allowed except whole brain irradiation for CNS disease
Surgery:
* Not specified
Other:
* At least 48 hours since prior or concurrent ethanol (CYP3A enzyme inducer) or grapefruit juice (CYP3A enzyme inhibitor)
* At least 7 days since prior or concurrent CYP450 inducing drugs:
* Antiseizure medications: phenobarbital, phenytoin, carbamazepine, or lamotrigine
* Anti-TB therapy: rifampin, isoniazid, or sulfinpyrazone
* At least 7 days since prior or concurrent CYP450 3A inhibiting drugs:
* Macrolides: erythromycin, clarithromycin, azithromycin, or roxithromycin
* Azoles: ketoconazole, fluconazole, or itraconazole
* Other antibiotics: metronidazole or chloramphenicol
* Anti-HIV drugs: ritonavir, indinavir, nelfinavir, or delavirdine
* Immunosuppressive agents: cyclosporine
* Antidepressant agent: nefazodone
18 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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Lionel Lewis, MD
Role: STUDY_CHAIR
Norris Cotton Cancer Center
Locations
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Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Saint Anthony Medical Center
Rockford, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 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
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, 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
Weill Medical College of Cornell University
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
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, 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
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, United States
McGill University
Montreal, Quebec, Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , Puerto Rico
Countries
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References
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Lewis LD, Miller AA, Rosner GL, Dowell JE, Valdivieso M, Relling MV, Egorin MJ, Bies RR, Hollis DR, Levine EG, Otterson GA, Millard F, Ratain MJ; Cancer and Leukemia Group B. A comparison of the pharmacokinetics and pharmacodynamics of docetaxel between African-American and Caucasian cancer patients: CALGB 9871. Clin Cancer Res. 2007 Jun 1;13(11):3302-11. doi: 10.1158/1078-0432.CCR-06-2345.
Other Identifiers
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CALGB-9871
Identifier Type: -
Identifier Source: secondary_id
CDR0000066631
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-9871
Identifier Type: -
Identifier Source: org_study_id
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