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A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Breast Cancer, Head and Neck Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Martha Jefferson HospitalCharlottesville, Virginia  22901
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
Helen and Harry Gray Cancer Institute at Good Samaritan Medical CenterWest Palm Beach, Florida  33401
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Weill Medical College of Cornell UniversityNew York, New York  10021
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
NorthEast Oncology AssociatesConcord, North Carolina  28025
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Ministry Medical Group - Northern RegionRhinelander, Wisconsin  54501