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
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer
Both
Head and Neck Cancer
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 Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| California Cancer Center | Fresno, California 93720 |
| Veterans Affairs Outpatient Clinic - Martinez | Martinez, California 94553 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Harrington Cancer Center | Amarillo, Texas 79106 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange, California 92868 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| MBCCOP - University of New Mexico HSC | Albuquerque, New Mexico 87131 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix, Arizona 85012 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock, Arkansas 72205 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Veterans Affairs Medical Center - Denver | Denver, 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 - Wichita | Wichita, Kansas 67218 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Louisiana State University Health Sciences Center - Shreveport | Shreveport, Louisiana 71130-3932 |
| Veterans Affairs Medical Center - Shreveport | Shreveport, Louisiana 71130 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Veterans Affairs Medical Center - Jackson | Jackson, Mississippi 39216 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Veterans Affairs Medical Center - Albuquerque | Albuquerque, New Mexico 87108-5138 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Veterans Affairs Medical Center - Portland | Portland, Oregon 97207 |
| Veterans Affairs Medical Center - Charleston | Charleston, South Carolina 29401-5799 |
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
| Veterans Affairs Medical Center - Temple | Temple, Texas 76504 |
| Veterans Affairs Medical Center - Salt Lake City | Salt Lake City, Utah 84148 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Veterans Affairs Medical Center - Seattle | Seattle, Washington 98108 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| Veterans Affairs Medical Center - New Orleans | New Orleans, Louisiana 70112 |
| Puget Sound Oncology Consortium | Seattle, Washington 98109 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| University of Tennessee Cancer Institute | Memphis, Tennessee 38103 |
| Veterans Affairs Medical Center - Amarillo | Amarillo, Texas 79106 |
| CCOP - Beaumont | Royal Oak, Michigan 48073-6769 |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
| Tulane Cancer Center at Tulane University Hospital and Clinic | New Orleans, Louisiana 70112 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| St. Louis University Hospital Cancer Center | Saint Louis, Missouri 63110 |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
| Veterans Affairs Medical Center - Salisbury | Salisbury, North Carolina 28144 |
| Cancer Institute at Oregon Health and Science University | Portland, Oregon 97201-3098 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| MBCCOP - Howard University Cancer Center | Washington, District of Columbia 20060 |
| Providence Cancer Institute at Providence Hospital | Southfield, Michigan 48075 |
