S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer.
調査の概要
詳細な説明
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.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile、Alabama、アメリカ、36607
- MBCCOP - Gulf Coast
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Arizona
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Phoenix、Arizona、アメリカ、85006-2726
- CCOP - Western Regional, Arizona
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Phoenix、Arizona、アメリカ、85012
- Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
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Tucson、Arizona、アメリカ、85723
- Veterans Affairs Medical Center - Tucson
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Tucson、Arizona、アメリカ、85724
- Arizona Cancer Center at University of Arizona Health Sciences Center
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Arkansas
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Little Rock、Arkansas、アメリカ、72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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Little Rock、Arkansas、アメリカ、72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte、California、アメリカ、91010-3000
- City of Hope Comprehensive Cancer Center
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Fresno、California、アメリカ、93720
- California Cancer Center
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Los Angeles、California、アメリカ、90033
- USC/Norris Comprehensive Cancer Center and Hospital
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Martinez、California、アメリカ、94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland、California、アメリカ、94609-3305
- CCOP - Bay Area Tumor Institute
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Orange、California、アメリカ、92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
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Sacramento、California、アメリカ、95817
- University of California Davis Cancer Center
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Santa Rosa、California、アメリカ、95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base、California、アメリカ、94535
- David Grant Medical Center
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Colorado
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Aurora、Colorado、アメリカ、80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Denver、Colorado、アメリカ、80220
- Veterans Affairs Medical Center - Denver
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District of Columbia
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Washington、District of Columbia、アメリカ、20060
- MBCCOP - Howard University Cancer Center
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Florida
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Tampa、Florida、アメリカ、33612
- Veterans Affairs Medical Center - Tampa (Haley)
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Georgia
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Atlanta、Georgia、アメリカ、30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu、Hawaii、アメリカ、96813
- MBCCOP - Hawaii
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Illinois
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Chicago、Illinois、アメリカ、60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago、Illinois、アメリカ、60612
- MBCCOP - University of Illinois at Chicago
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Decatur、Illinois、アメリカ、62526
- CCOP - Central Illinois
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Hines、Illinois、アメリカ、60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood、Illinois、アメリカ、60153-5500
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
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Kansas
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Kansas City、Kansas、アメリカ、66160-7353
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Wichita、Kansas、アメリカ、67214-3882
- CCOP - Wichita
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Wichita、Kansas、アメリカ、67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington、Kentucky、アメリカ、40502-2236
- Veterans Affairs Medical Center - Lexington
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Lexington、Kentucky、アメリカ、40536-0084
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans、Louisiana、アメリカ、70112
- MBCCOP - LSU Health Sciences Center
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New Orleans、Louisiana、アメリカ、70112
- Tulane Cancer Center at Tulane University Hospital and Clinic
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Shreveport、Louisiana、アメリカ、71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport、Louisiana、アメリカ、71101-4295
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Cancer Research Center at Boston Medical Center
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Michigan
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Ann Arbor、Michigan、アメリカ、48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor、Michigan、アメリカ、48106
- CCOP - Michigan Cancer Research Consortium
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Ann Arbor、Michigan、アメリカ、48109-0912
- University of Michigan Comprehensive Cancer Center
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Detroit、Michigan、アメリカ、48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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Detroit、Michigan、アメリカ、48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit、Michigan、アメリカ、48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids、Michigan、アメリカ、49503
- CCOP - Grand Rapids
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Royal Oak、Michigan、アメリカ、48073-6769
- CCOP - Beaumont
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Southfield、Michigan、アメリカ、48075
- Providence Cancer Institute at Providence Hospital
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Mississippi
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Jackson、Mississippi、アメリカ、39216-4505
- University of Mississippi Medical Center
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Jackson、Mississippi、アメリカ、39216
- Veterans Affairs Medical Center - Jackson
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Missouri
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Kansas City、Missouri、アメリカ、64131
- CCOP - Kansas City
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Saint Louis、Missouri、アメリカ、63141
- CCOP - St. Louis-Cape Girardeau
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Saint Louis、Missouri、アメリカ、63110
- St. Louis University Hospital Cancer Center
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Springfield、Missouri、アメリカ、65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings、Montana、アメリカ、59101
- CCOP - Montana Cancer Consortium
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New Jersey
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East Orange、New Jersey、アメリカ、07018-1095
- Veterans Affairs Medical Center - East Orange
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New Mexico
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Albuquerque、New Mexico、アメリカ、87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque、New Mexico、アメリカ、87131
- MBCCOP - University of New Mexico HSC
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New York
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New York、New York、アメリカ、10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York、New York、アメリカ、10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Rochester、New York、アメリカ、14642
- James P. Wilmot Cancer Center at University of Rochester Medical Center
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North Carolina
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Salisbury、North Carolina、アメリカ、28144
- Veterans Affairs Medical Center - Salisbury
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Winston-Salem、North Carolina、アメリカ、27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati、Ohio、アメリカ、45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati、Ohio、アメリカ、45267-0501
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland、Ohio、アメリカ、44195-9001
- Cleveland Clinic Taussig Cancer Center
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Columbus、Ohio、アメリカ、43206
- CCOP - Columbus
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Dayton、Ohio、アメリカ、45429
- CCOP - Dayton
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Dayton、Ohio、アメリカ、45428-1002
- Veterans Affairs Medical Center - Dayton
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Oregon
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Portland、Oregon、アメリカ、97207
- Veterans Affairs Medical Center - Portland
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Portland、Oregon、アメリカ、97225
- CCOP - Columbia River Oncology Program
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Portland、Oregon、アメリカ、97201-3098
- Cancer Institute at Oregon Health and Science University
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Hollings Cancer Center at Medical University of South Carolina
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Charleston、South Carolina、アメリカ、29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville、South Carolina、アメリカ、29615
- CCOP - Greenville
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Spartanburg、South Carolina、アメリカ、29303
- CCOP - Upstate Carolina
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Tennessee
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Memphis、Tennessee、アメリカ、38104
- University of Tennessee Cancer Institute
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Texas
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Amarillo、Texas、アメリカ、79106
- Harrington Cancer Center
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Amarillo、Texas、アメリカ、79106
- Veterans Affairs Medical Center - Amarillo
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Fort Sam Houston、Texas、アメリカ、78234-6200
- Brooke Army Medical Center
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Galveston、Texas、アメリカ、77555-0565
- University of Texas Medical Branch
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Houston、Texas、アメリカ、77030
- Veterans Affairs Medical Center - Houston
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Houston、Texas、アメリカ、77030-4095
- University of Texas - MD Anderson Cancer Center
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San Antonio、Texas、アメリカ、78229-3900
- University of Texas Health Science Center at San Antonio
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San Antonio、Texas、アメリカ、78229
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple、Texas、アメリカ、76504
- Veterans Affairs Medical Center - Temple
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Temple、Texas、アメリカ、76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City、Utah、アメリカ、84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City、Utah、アメリカ、84112-5550
- Huntsman Cancer Institute
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Washington
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Seattle、Washington、アメリカ、98101
- CCOP - Virginia Mason Research Center
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Seattle、Washington、アメリカ、98108
- Veterans Affairs Medical Center - Seattle
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Seattle、Washington、アメリカ、98109
- Puget Sound Oncology Consortium
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Tacoma、Washington、アメリカ、98431-5000
- Madigan Army Medical Center
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Tacoma、Washington、アメリカ、98405-0986
- CCOP - Northwest
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Ontario
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Toronto、Ontario、カナダ、M5G 1X8
- Hospital for Sick Children
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000269781
- U10CA032102 (米国 NIH グラント/契約)
- S0216 (その他の識別子:SWOG)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。