Docetaxel in Treating Patients With Solid Tumors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003565
• Other study ID #: CALGB-9871
• Secondary ID: U10CA031946CALGB
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 12, 2016
• Start date: September 1998
• Est. completion date: January 2008

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2008
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Breast Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Lung Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific
• Urinary Bladder Neoplasms

Intervention

Drug:
• docetaxel

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Quebec
Puerto Rico	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan
United States	Northeast Alabama Regional Medical Center	Anniston	Alabama
United States	Veterans Affairs Medical Center - Asheville	Asheville	North Carolina
United States	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Martha Jefferson Hospital	Charlottesville	Virginia
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	NorthEast Oncology Associates	Concord	North Carolina
United States	Veterans Affairs Medical Center - Dallas	Dallas	Texas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - Durham	Durham	North Carolina
United States	Elmhurst Hospital Center	Elmhurst	New York
United States	Veterans Affairs Medical Center - Fargo	Fargo	North Dakota
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana
United States	Memorial Regional Hospital Comprehensive Cancer Center	Hollywood	Florida
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	Lenoir Memorial Hospital Cancer Center	Kinston	North Carolina
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Veterans Affairs Medical Center - Las Vegas	Las Vegas	Nevada
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Baptist Hospital East - Louisville	Louisville	Kentucky
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	North Shore University Hospital	Manhasset	New York
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai Medical Center, NY	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Virginia Oncology Associates - Norfolk	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina
United States	Lifespan: The Miriam Hospital	Providence	Rhode Island
United States	Ministry Medical Group - Northern Region	Rhinelander	Wisconsin
United States	MBCCOP - Massey Cancer Center	Richmond	Virginia
United States	West Suburban Center for Cancer Care	River Forest	Illinois
United States	Oncology and Hematology Associates of Southwest Virginia, Inc.	Roanoke	Virginia
United States	Saint Anthony Medical Center	Rockford	Illinois
United States	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Veterans Affairs Medical Center - San Diego	San Diego	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Veterans Affairs Medical Center - San Francisco	San Francisco	California
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Veterans Affairs Medical Center - Syracuse	Syracuse	New York
United States	Lombardi Cancer Center	Washington	District of Columbia
United States	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center	West Palm Beach	Florida
United States	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont
United States	New Hanover Regional Medical Center	Wilmington	North Carolina
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (1)

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 A — View Citation