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A RANDOMIZED PHASE III EVALUATION OF PACLITAXEL + G-CSF + CISPLATIN VERSUS CISPLATIN + 5-FU IN ADVANCED HEAD AND NECK CANCER


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A RANDOMIZED PHASE III EVALUATION OF PACLITAXEL + G-CSF + CISPLATIN VERSUS CISPLATIN + 5-FU IN ADVANCED HEAD AND NECK CANCER


OBJECTIVES: I. Compare the response rate, toxicity, quality-of-life, and overall survival at
1 year in patients with advanced head and neck carcinomas when treated with paclitaxel and
cisplatin vs cisplatin and fluorouracil. II. Compare these regimens in terms of quality of
life and correlate quality of life to toxicity in these patients. III. Compare these
regimens in terms of pain intensity and correlate pain with quality of life and toxicity in
these patients.

OUTLINE: This is a randomized study. Patients are stratified by disease status, performance
status, and participating institution. Patients are randomized to one of two treatment arms.
Arm I: Patients receive cisplatin IV over 30-120 minutes on day 1 and fluorouracil IV over
96 hours on days 1-4. Courses repeat every 3 weeks in the absence of disease progression or
unacceptable toxicity. Arm II: Patients receive paclitaxel IV over 3 hours followed by
cisplatin IV over 30-120 minutes on day 1. Courses repeat every 3 weeks in the absence of
disease progression or unacceptable toxicity. Treatment continues until 2 courses past
complete response (minimum of 6 courses). Patients with stable disease may discontinue
treatment after 6 courses. Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 212 patients will be accrued for this study over 2.25 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and
neck considered incurable by surgery or radiotherapy Newly diagnosed extensive
locoregional disease or distant metastases Locoregionally recurrent or persistent disease,
or distant metastases occurring after initial surgery or radiotherapy No nasopharyngeal
carcinoma No history of brain metastases Measurable or evaluable disease Documented
progressive disease or biopsy-proven residual carcinoma required if sole measurable site
previously irradiated

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic:
ANC at least 1,500/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic:
Bilirubin less than 1.5 mg/dL AST/ALT no greater than twice normal Alkaline phosphatase no
greater than twice normal Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine
clearance at least 50 mL/min Calcium normal No history of hypercalcemia Cardiovascular: No
congestive heart failure No serious arrhythmia requiring medication No myocardial
infarction within 6 months No medications known to alter cardiac conduction (i.e.,
lanoxin, beta or calcium channel blockers) Other: No significant detectable or occult
infection Complete evaluation required if elevated WBC (12,000 or greater) or fever (101.6
F or higher) No hypersensitivity to E. coli-derived proteins No allergy to drugs utilizing
Cremophor No other malignancy within 3 years except curatively treated nonmelanomatous
skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test
Fertile patients must use effective contraception Must complete quality of life and pain
assessments at required intervals

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for recurrent disease At least 12 months since induction or neoadjuvant
chemotherapy with paclitaxel or fluorouracil (6 months since cisplatin) Endocrine therapy:
Not specified Radiotherapy: See Disease Characteristics Surgery: Recovered from major
surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Arlene A. Forastiere, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065210

NCT ID:

NCT00002888

Start Date:

March 1997

Completion Date:

August 2004

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • 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 IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Head and Neck Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
MBCCOP - University of South AlabamaMobile, Alabama  36688
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
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
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
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
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
Swedish Hospital Tumor InstituteSeattle, Washington  98104
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Louisiana State University Hospital - ShreveportShreveport, Louisiana  71130-3932
CCOP - Ozarks RegionalSpringfield, Missouri  65807