A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Breast Cancer, Head and Neck Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Both
Bladder Cancer, Breast Cancer, Head and Neck Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Lionel D. Lewis, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Norris Cotton Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066631
NCT ID:
NCT00003565
Start Date:
September 1998
Completion Date:
January 2006
Related Keywords:
- Bladder Cancer
- Breast Cancer
- Head and Neck Cancer
- Lung Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- recurrent non-small cell lung cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- stage III bladder cancer
- recurrent bladder cancer
- stage IV bladder cancer
- stage IV nasopharyngeal cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- unspecified adult solid tumor, protocol specific
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- pulmonary carcinoid tumor
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III basal cell carcinoma of the lip
- stage III verrucous carcinoma of the oral cavity
- stage III mucoepidermoid carcinoma of the oral cavity
- stage III adenoid cystic carcinoma of the oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV basal cell carcinoma of the lip
- stage IV verrucous carcinoma of the oral cavity
- stage IV mucoepidermoid carcinoma of the oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent basal cell carcinoma of the lip
- recurrent verrucous carcinoma of the oral cavity
- recurrent mucoepidermoid carcinoma of the oral cavity
- recurrent adenoid cystic carcinoma of the oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage III lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage IV lymphoepithelioma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- recurrent lymphoepithelioma of the oropharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage III lymphoepithelioma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage IV lymphoepithelioma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent lymphoepithelioma of the nasopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III verrucous carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage IV verrucous carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- recurrent verrucous carcinoma of the larynx
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III inverted papilloma of the paranasal sinus and nasal cavity
- stage III midline lethal granuloma of the paranasal sinus and nasal cavity
- stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent inverted papilloma of the paranasal sinus and nasal cavity
- recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- Urinary Bladder Neoplasms
- Breast Neoplasms
- Head and Neck Neoplasms
- Lung Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
| Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Mount Sinai Medical Center, NY | New York, New York 10029 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
| Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
| MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
| North Shore University Hospital | Manhasset, New York 11030 |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
| Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
| Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
| Baptist Hospital East - Louisville | Louisville, Kentucky 40207 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| Veterans Affairs Medical Center - Fargo | Fargo, North Dakota 58102 |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Roanoke, Virginia 24014 |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
| Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
| Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Broward General Medical Center | Fort Lauderdale, Florida 33316 |
| Florida Hospital Cancer Institute | Orlando, Florida 32804 |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Northeast Alabama Regional Medical Center | Anniston, Alabama 36207 |
| Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| Veterans Affairs Medical Center - Washington, DC | Washington, District of Columbia 20422 |
| Memorial Regional Hospital Comprehensive Cancer Center | Hollywood, Florida 33021 |
| Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center | West Palm Beach, Florida 33401 |
| Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
| West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
| Saint Anthony Medical Center | Rockford, Illinois 61108 |
| Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
| Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
| Lakeland Medical Center - St. Joseph | Saint Joseph, Michigan 49085 |
| Veterans Affairs Medical Center - Las Vegas | Las Vegas, Nevada 89106 |
| Cooper University Hospital | Camden, New Jersey 08103 |
| Elmhurst Hospital Center | Elmhurst, New York 11373 |
| Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
| Weill Medical College of Cornell University | New York, New York 10021 |
| Veterans Affairs Medical Center - Asheville | Asheville, North Carolina 28805 |
| NorthEast Oncology Associates | Concord, North Carolina 28025 |
| Cape Fear Valley Health System | Fayetteville, North Carolina 28302-2000 |
| Lenoir Memorial Hospital Cancer Center | Kinston, North Carolina 28503-1678 |
| FirstHealth Moore Regional Hospital | Pinehurst, North Carolina 28374 |
| New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
| Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
| Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
| Virginia Oncology Associates - Norfolk | Norfolk, Virginia 23502 |
| St. Mary's Medical Center | Huntington, West Virginia 25701 |
| Ministry Medical Group - Northern Region | Rhinelander, Wisconsin 54501 |
