Docetaxel in Treating Patients With Solid Tumors

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003565
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 109
• Locations: 74
• Arm: 1
• Duration (Months): 112
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of Population Pharmacokinetics of Docetaxel (Taxotere) in Caucasian and African-American Cancer Patients
• Study Start Date: Sep 1, 1998
• Actual Primary Completion Date: Jan 1, 2006
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

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.	Drug: docetaxel

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northeast Alabama Regional Medical Center	Anniston	Alabama	United States	36207
2	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
3	Veterans Affairs Medical Center - San Diego	San Diego	California	United States	92161
4	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94115
5	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
6	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
7	Lombardi Cancer Center	Washington	District of Columbia	United States	20007
8	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
9	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia	United States	20422
10	Broward General Medical Center	Fort Lauderdale	Florida	United States	33316
11	Memorial Regional Hospital Comprehensive Cancer Center	Hollywood	Florida	United States	33021
12	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
13	Florida Hospital Cancer Institute	Orlando	Florida	United States	32804
14	Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center	West Palm Beach	Florida	United States	33401
15	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612
16	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
17	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
18	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
19	West Suburban Center for Cancer Care	River Forest	Illinois	United States	60305
20	Saint Anthony Medical Center	Rockford	Illinois	United States	61108
21	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana	United States	46885-5099
22	Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242-1009
23	Baptist Hospital East - Louisville	Louisville	Kentucky	United States	40207
24	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
25	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland	United States	21201
26	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
27	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts	United States	01655
28	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan	United States	49085
29	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
30	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
31	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
32	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
33	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
34	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
35	Veterans Affairs Medical Center - Las Vegas	Las Vegas	Nevada	United States	89106
36	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756-0002
37	Cooper University Hospital	Camden	New Jersey	United States	08103
38	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
39	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
40	Elmhurst Hospital Center	Elmhurst	New York	United States	11373
41	Queens Cancer Center of Queens Hospital	Jamaica	New York	United States	11432
42	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
43	North Shore University Hospital	Manhasset	New York	United States	11030
44	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
45	Weill Medical College of Cornell University	New York	New York	United States	10021
46	Mount Sinai Medical Center, NY	New York	New York	United States	10029
47	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
48	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
49	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
50	Veterans Affairs Medical Center - Asheville	Asheville	North Carolina	United States	28805
51	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
52	NorthEast Oncology Associates	Concord	North Carolina	United States	28025
53	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
54	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
55	Cape Fear Valley Health System	Fayetteville	North Carolina	United States	28302-2000
56	Lenoir Memorial Hospital Cancer Center	Kinston	North Carolina	United States	28503-1678
57	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina	United States	28374
58	New Hanover Regional Medical Center	Wilmington	North Carolina	United States	28402-9025
59	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
60	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
61	Veterans Affairs Medical Center - Fargo	Fargo	North Dakota	United States	58102
62	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
63	Lifespan: The Miriam Hospital	Providence	Rhode Island	United States	02906
64	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105-2794
65	Veterans Affairs Medical Center - Dallas	Dallas	Texas	United States	75216
66	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont	United States	05009
67	Martha Jefferson Hospital	Charlottesville	Virginia	United States	22902
68	Virginia Oncology Associates - Norfolk	Norfolk	Virginia	United States	23502
69	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037
70	Oncology and Hematology Associates of Southwest Virginia, Inc.	Roanoke	Virginia	United States	24014
71	St. Mary's Medical Center	Huntington	West Virginia	United States	25701
72	Ministry Medical Group - Northern Region	Rhinelander	Wisconsin	United States	54501
73	McGill University	Montreal	Quebec	Canada	H2W 1S6
74	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
• National Cancer Institute (NCI)

Investigators

• Study Chair: Lionel Lewis, MD, Norris Cotton Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00003565
• Other Study ID Numbers: CALGB-9871; U10CA031946; CALGB-9871; CDR0000066631
• First Posted: Jan 27, 2003
• Last Update Posted: Jul 14, 2016
• Last Verified: Jul 1, 2016

• 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; 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
• Additional relevant MeSH terms: Breast Neoplasms; Lung Neoplasms; Head and Neck Neoplasms; Urinary Bladder Neoplasms; Docetaxel

Study Results

No Results Posted as of Jul 14, 2016