- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003565
Docetaxel in Treating Patients With Solid Tumors
A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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San Juan, Puerto Rico, 00936-5067
- University of Puerto Rico School of Medicine Medical Sciences Campus
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Alabama
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Anniston, Alabama, United States, 36207
- Northeast Alabama Regional Medical Center
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California
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La Jolla, California, United States, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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San Diego, California, United States, 92161
- Veterans Affairs Medical Center - San Diego
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San Francisco, California, United States, 94115
- UCSF Comprehensive Cancer Center
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San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
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Delaware
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, United States, 20422
- Veterans Affairs Medical Center - Washington, DC
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Washington, District of Columbia, United States, 20007
- Lombardi Cancer Center
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward General Medical Center
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Hollywood, Florida, United States, 33021
- Memorial Regional Hospital Comprehensive Cancer Center
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, United States, 32804
- Florida Hospital Cancer Institute
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West Palm Beach, Florida, United States, 33401
- Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
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Illinois
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Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, United States, 60640
- Louis A. Weiss Memorial Hospital
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Chicago, Illinois, United States, 60612
- MBCCOP - University of Illinois at Chicago
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River Forest, Illinois, United States, 60305
- West Suburban Center for Cancer Care
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Rockford, Illinois, United States, 61108
- Saint Anthony Medical Center
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Indiana
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Fort Wayne, Indiana, United States, 46885-5099
- Fort Wayne Medical Oncology and Hematology, Incorporated
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center
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Kentucky
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Louisville, Kentucky, United States, 40207
- Baptist Hospital East - Louisville
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Maryland
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Baltimore, Maryland, United States, 21201
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
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Baltimore, Maryland, United States, 21201
- Veterans Affairs Medical Center - Baltimore
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center - University Campus
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Michigan
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Saint Joseph, Michigan, United States, 49085
- Lakeland Medical Center - St. Joseph
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
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Missouri
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Columbia, Missouri, United States, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, United States, 68198-7680
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas, Nevada, United States, 89106
- Veterans Affairs Medical Center - Las Vegas
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper University Hospital
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, United States, 14215
- Veterans Affairs Medical Center - Buffalo
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Elmhurst, New York, United States, 11373
- Elmhurst Hospital Center
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Jamaica, New York, United States, 11432
- Queens Cancer Center of Queens Hospital
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Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10029
- Mount Sinai Medical Center, NY
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New York, New York, United States, 10021
- Weill Medical College of Cornell University
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, United States, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Asheville, North Carolina, United States, 28805
- Veterans Affairs Medical Center - Asheville
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Concord, North Carolina, United States, 28025
- NorthEast Oncology Associates
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Durham, North Carolina, United States, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Fayetteville, North Carolina, United States, 28302-2000
- Cape Fear Valley Health System
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Kinston, North Carolina, United States, 28503-1678
- Lenoir Memorial Hospital Cancer Center
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Pinehurst, North Carolina, United States, 28374
- Firsthealth Moore Regional Hospital
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Wilmington, North Carolina, United States, 28402-9025
- New Hanover Regional Medical Center
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Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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North Dakota
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Fargo, North Dakota, United States, 58102
- Veterans Affairs Medical Center - Fargo
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Lifespan: The Miriam Hospital
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Tennessee
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Memphis, Tennessee, United States, 38105-2794
- St. Jude Children's Research Hospital
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Texas
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Dallas, Texas, United States, 75216
- Veterans Affairs Medical Center - Dallas
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Vermont
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White River Junction, Vermont, United States, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Charlottesville, Virginia, United States, 22902
- Martha Jefferson Hospital
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates - Norfolk
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Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
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Roanoke, Virginia, United States, 24014
- Oncology and Hematology Associates of Southwest Virginia, Inc.
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West Virginia
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Huntington, West Virginia, United States, 25701
- St. Mary's Medical Center
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Wisconsin
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Rhinelander, Wisconsin, United States, 54501
- Ministry Medical Group - Northern Region
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- Immunosuppressive agents: cyclosporine
- Antidepressant agent: nefazodone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: docetaxel
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.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Lionel Lewis, MD, Norris Cotton Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB 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 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
- 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 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 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 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
- stage IIIC breast cancer
- recurrent inverted papilloma of the paranasal sinus and nasal cavity
- stage III inverted papilloma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- stage IV nasopharyngeal cancer
- pulmonary carcinoid tumor
Additional Relevant MeSH Terms
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Breast Neoplasms
- Head and Neck Neoplasms
- Lung Neoplasms
- Urinary Bladder Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- CALGB-9871
- U10CA031946 (U.S. NIH Grant/Contract)
- CDR0000066631 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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