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Docetaxel (NSC-628503), Cisplatin (NSC-119875), And 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed By Accelerated Fractionation/Concomitant Boost Radiation And Concurrent Single Agent Cisplatin (NSC-119875), In Patients With Advanced Squamous Cell Head And Neck Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Docetaxel (NSC-628503), Cisplatin (NSC-119875), And 5-Fluorouracil (NSC-19893) Induction Chemotherapy Followed By Accelerated Fractionation/Concomitant Boost Radiation And Concurrent Single Agent Cisplatin (NSC-119875), In Patients With Advanced Squamous Cell Head And Neck Cancer


OBJECTIVES:

- Determine the overall survival of patients with stage III or IV squamous cell head and
neck cancer treated with docetaxel, cisplatin, and fluorouracil followed by accelerated
fractionation/concomitant boost radiotherapy and cisplatin.

- Determine the unconfirmed complete response rate in these patients after treatment with
induction chemotherapy.

- Determine the overall complete response rate (confirmed and unconfirmed) in patients
treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

OUTLINE:

- Induction Chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over
30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats
every 21 days for 2 courses in the absence of unacceptable toxicity.

- Chemoradiotherapy: Beginning within 3-4 weeks after administration of the second course
of induction chemotherapy, patients receive accelerated fractionation radiotherapy once
daily, 5 days per week, for 6 weeks with concomitant boost radiotherapy once daily, 5
days a week, for the last 2.5 weeks of radiotherapy. Patients also receive concurrent
cisplatin IV over 30-60 minutes on days 1 and 22.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months
for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the head and neck (excluding lip,
nasopharynx, paranasal sinus, and salivary gland) by biopsy or fine needle aspirate
of the primary lesion or neck mass

- Stage III or IV disease

- No evidence of distant metastases

- Negative chest x-ray

- Primary site in the head and neck region must be identified

- No unknown primary site

- Considered to be appropriate for definitive radiotherapy with curative intent

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic

- Bilirubin no greater than upper limit of normal (ULN)

- Alkaline phosphatase less than 2 times ULN

- ALT or AST less than 1.5 times ULN

Renal

- Creatinine less than 1.5 mg/dL

Cardiovascular

- No myocardial infarction within the past 3 months

- No unstable or uncontrolled angina

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately
treated stage I or II cancer currently in complete remission

- No evidence of pre-existing peripheral neuropathy

- No active systemic infection

- No history of hypersensitivity reaction to products containing polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- No prior radiotherapy

Surgery

- No prior surgery for head or neck cancer

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David J. Adelstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000269781

NCT ID:

NCT00054054

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the oropharynx
  • Head and Neck Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
California Cancer CenterFresno, California  93720
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Grand RapidsGrand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Puget Sound Oncology ConsortiumSeattle, Washington  98109
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
St. Louis University Hospital Cancer CenterSaint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Veterans Affairs Medical Center - SalisburySalisbury, North Carolina  28144
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Providence Cancer Institute at Providence HospitalSouthfield, Michigan  48075