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Docetaxel in Treating Patients With Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Docetaxel in Treating Patients With Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Docetaxel in Treating Patients With Solid Tumors Clinical research trials and Docetaxel in Treating Patients With Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Docetaxel in Treating Patients With Solid Tumors. Docetaxel in Treating Patients With Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Docetaxel in Treating Patients With Solid Tumors clinical trial. Subjects typically recieve the finest healthcare available for their Docetaxel in Treating Patients With Solid Tumors condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Patients With Solid Tumors Docetaxel in Treating Patients With Solid Tumors
Docetaxel in Treating Patients With Solid Tumors
For Condition: kidney and urinary cancer,Head and Neck Cancer,adult solid tumor,Breast Cancer,thorax and respiratory cancer
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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 compare the effectiveness of docetaxel in treating Caucasian and African American patients who have solid tumors.
Details: OBJECTIVES: - 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. PROJECTED ACCRUAL: Approximately 80 patients (40 Caucasian and 40 African American) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Not specified Menopausal status: - Not specified Performance status: - 0-2 Life expectancy: - Not specified 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LionelLewis, Study Chair, Norris Cotton Cancer Center
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
Cooper University Hospital
Camden, New Jersey, 08103
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Additional Information:
Study ID Numbers: CDR0000066631; CLB-9871
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003565
Other Adult Solid Tumor Studies:
1. ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer
2. Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia
3. Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
4. Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer
5. Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
Related Studies:
Other adult solid tumor Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
Docetaxel in Treating Patients With Solid Tumors
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