Docetaxel in Treating Patients With Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003565
First received: November 1, 1999
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Breast Cancer
Head and Neck Cancer
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Enrollment: 109
Study Start Date: September 1998
Study Completion Date: January 2008
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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.

PROJECTED ACCRUAL: Approximately 80 patients (40 Caucasian and 40 African American) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003565

  Hide Study Locations
Locations
United States, Alabama
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
United States, California
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, United States, 33021
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, United States, 33401
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Baptist Hospital East - Louisville
Louisville, Kentucky, United States, 40207
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore University Hospital
Manhasset, New York, United States, 11030
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Weill Medical College of Cornell University
New York, New York, United States, 10021
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
United States, North Carolina
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
NorthEast Oncology Associates
Concord, North Carolina, United States, 28025
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Cape Fear Valley Health System
Fayetteville, North Carolina, United States, 28302-2000
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States, 28503-1678
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402-9025
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
United States, North Dakota
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, United States, 58102
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Rhode Island
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75216
United States, Vermont
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22902
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States, 23502
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States, 24014
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, United States, 54501
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Lionel D. Lewis, MD Norris Cotton Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003565     History of Changes
Other Study ID Numbers: CDR0000066631, U10CA031946, CLB-9871
Study First Received: November 1, 1999
Last Updated: September 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
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

Additional relevant MeSH terms:
Lung Neoplasms
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Breast Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014