A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients
Acronym
Not provided
Organization
Alliance for Clinical Trials in OncologyOTHER
Status Module
Record Verification Date
Jul 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 1998
Primary Completion Date
Jan 2006Actual
Completion Date
Jan 2008Actual
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 12, 2016
Last Update Posted Date
Jul 14, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alliance for Clinical Trials in OncologyOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
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.
Conditions Module
Conditions
Bladder Cancer
Breast Cancer
Head and Neck Cancer
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
109Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
docetaxel
Experimental
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.
Drug: docetaxel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
docetaxel
Drug
docetaxel
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility 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)
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
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
La Jolla
California
92093-0658
United States
Veterans Affairs Medical Center - San Diego
San Diego
California
92161
United States
UCSF Comprehensive Cancer Center
San Francisco
California
94115
United States
Veterans Affairs Medical Center - San Francisco
San Francisco
California
94121
United States
CCOP - Christiana Care Health Services
Newark
Delaware
19713
United States
Lombardi Cancer Center
Washington D.C.
District of Columbia
20007
United States
Walter Reed Army Medical Center
Washington D.C.
District of Columbia
20307-5000
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C.
District of Columbia
20422
United States
Broward General Medical Center
Fort Lauderdale
Florida
33316
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood
Florida
33021
United States
CCOP - Mount Sinai Medical Center
Miami Beach
Florida
33140
United States
Florida Hospital Cancer Institute
Orlando
Florida
32804
United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach
Florida
33401
United States
MBCCOP - University of Illinois at Chicago
Chicago
Illinois
60612
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago
Illinois
60612
United States
University of Chicago Cancer Research Center
Chicago
Illinois
60637-1470
United States
Louis A. Weiss Memorial Hospital
Chicago
Illinois
60640
United States
West Suburban Center for Cancer Care
River Forest
Illinois
60305
United States
Saint Anthony Medical Center
Rockford
Illinois
61108
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne
Indiana
46885-5099
United States
Holden Comprehensive Cancer Center
Iowa City
Iowa
52242-1009
United States
Baptist Hospital East - Louisville
Louisville
Kentucky
40207
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore
Maryland
21201
United States
Veterans Affairs Medical Center - Baltimore
Baltimore
Maryland
21201
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston
Massachusetts
02115
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester
Massachusetts
01655
United States
Lakeland Medical Center - St. Joseph
Saint Joseph
Michigan
49085
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis
Minnesota
55417
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia
Missouri
65201
United States
Ellis Fischel Cancer Center - Columbia
Columbia
Missouri
65203
United States
Barnes-Jewish Hospital
St Louis
Missouri
63110
United States
University of Nebraska Medical Center
Omaha
Nebraska
68198-7680
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas
Nevada
89106
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas
Nevada
89106
United States
Norris Cotton Cancer Center
Lebanon
New Hampshire
03756-0002
United States
Cooper University Hospital
Camden
New Jersey
08103
United States
Veterans Affairs Medical Center - Buffalo
Buffalo
New York
14215
United States
Roswell Park Cancer Institute
Buffalo
New York
14263-0001
United States
Elmhurst Hospital Center
Elmhurst
New York
11373
United States
Queens Cancer Center of Queens Hospital
Jamaica
New York
11432
United States
CCOP - North Shore University Hospital
Manhasset
New York
11030
United States
North Shore University Hospital
Manhasset
New York
11030
United States
Memorial Sloan-Kettering Cancer Center
New York
New York
10021
United States
Weill Medical College of Cornell University
New York
New York
10021
United States
Mount Sinai Medical Center, NY
New York
New York
10029
United States
State University of New York - Upstate Medical University
Syracuse
New York
13210
United States
Veterans Affairs Medical Center - Syracuse
Syracuse
New York
13210
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse
New York
13217
United States
Veterans Affairs Medical Center - Asheville
Asheville
North Carolina
28805
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill
North Carolina
27599-7295
United States
NorthEast Oncology Associates
Concord
North Carolina
28025
United States
Veterans Affairs Medical Center - Durham
Durham
North Carolina
27705
United States
Duke Comprehensive Cancer Center
Durham
North Carolina
27710
United States
Cape Fear Valley Health System
Fayetteville
North Carolina
28302-2000
United States
Lenoir Memorial Hospital Cancer Center
Kinston
North Carolina
28503-1678
United States
FirstHealth Moore Regional Hospital
Pinehurst
North Carolina
28374
United States
New Hanover Regional Medical Center
Wilmington
North Carolina
28402-9025
United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem
North Carolina
27104-4241
United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem
North Carolina
27157-1082
United States
Veterans Affairs Medical Center - Fargo
Fargo
North Dakota
58102
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus
Ohio
43210-1240
United States
Lifespan: The Miriam Hospital
Providence
Rhode Island
02906
United States
St. Jude Children's Research Hospital
Memphis
Tennessee
38105-2794
United States
Veterans Affairs Medical Center - Dallas
Dallas
Texas
75216
United States
Veterans Affairs Medical Center - White River Junction
White River Junction
Vermont
05009
United States
Martha Jefferson Hospital
Charlottesville
Virginia
22902
United States
Virginia Oncology Associates - Norfolk
Norfolk
Virginia
23502
United States
MBCCOP - Massey Cancer Center
Richmond
Virginia
23298-0037
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke
Virginia
24014
United States
St. Mary's Medical Center
Huntington
West Virginia
25701
United States
Ministry Medical Group - Northern Region
Rhinelander
Wisconsin
54501
United States
McGill University
Montreal
Quebec
H2W 1S6
Canada
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan
00936-5067
Puerto Rico
ID
Term
D001749
Urinary Bladder Neoplasms
D001943
Breast Neoplasms
D006258
Head and Neck Neoplasms
D008175
Lung Neoplasms
D002289
Carcinoma, Non-Small-Cell Lung
D055752
Small Cell Lung Carcinoma
D009303
Nasopharyngeal Neoplasms
D000077195
Squamous Cell Carcinoma of Head and Neck
D018304
Esthesioneuroblastoma, Olfactory
D012468
Salivary Gland Neoplasms
Ancestor Terms
ID
Term
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications