Combination Chemotherapy in Treating Patients With Advanced Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002888
• Other study ID #: CDR0000065210
• Secondary ID: E-1395SWOG-E1395
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: June 20, 2013
• Start date: March 1997
• Est. completion date: August 2004

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin plus fluorouracil are more effective than paclitaxel plus cisplatin in treating patients with advanced head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with advanced head and neck cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

• paclitaxel

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Research & Treatment Center	Albuquerque	New Mexico
United States	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	CCOP - Southwestern Vermont Regional Cancer Center	Bennington	Vermont
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi
United States	Boston Medical Center	Boston	Massachusetts
United States	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Veterans Affairs Medical Center - Denver	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Veterans Affairs Medical Center - Detroit	Detroit	Michigan
United States	Beckman Research Institute, City of Hope	Duarte	California
United States	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	University of Texas Medical Branch	Galveston	Texas
United States	CCOP - Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	CCOP - Greenville	Greenville	South Carolina
United States	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi
United States	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts
United States	CCOP - Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi
United States	CCOP - Dayton	Kettering	Ohio
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas
United States	Veterans Affairs Medical Center - Long Beach	Long Beach	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Texas Tech University Health Science Center	Lubbock	Texas
United States	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	MBCCOP - University of South Alabama	Mobile	Alabama
United States	MBCCOP - LSU Medical Center	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Veterans Affairs Medical Center - New Orleans	New Orleans	Louisiana
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	Veterans Affairs Medical Center - Phoenix (Hayden)	Phoenix	Arizona
United States	CCOP - Columbia River Program	Portland	Oregon
United States	Oregon Cancer Center at Oregon Health Sciences University	Portland	Oregon
United States	Veterans Affairs Medical Center - Portland	Portland	Oregon
United States	University of California Davis Medical Center	Sacramento	California
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Swedish Hospital Tumor Institute	Seattle	Washington
United States	Veterans Affairs Medical Center - Seattle	Seattle	Washington
United States	Louisiana State University Hospital - Shreveport	Shreveport	Louisiana
United States	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana
United States	Providence Hospital - Southfield	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Central Illinois	Springfield	Illinois
United States	CCOP - Ozarks Regional	Springfield	Missouri
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Veterans Affairs Medical Center - Temple	Temple	Texas
United States	David Grant Medical Center	Travis Air Force Base	California
United States	Arizona Cancer Center	Tucson	Arizona
United States	Veterans Affairs Medical Center - Tucson	Tucson	Arizona
United States	CCOP - Wichita	Wichita	Kansas
United States	Veterans Affairs Medical Center - Wichita	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI), Southwest Oncology Group

Country where clinical trial is conducted

United States, 

References & Publications (5)

Argiris A, Li Y, Forastiere A, et al.: Prognostic factors and long-term survivorship in patients with recurrent or metastatic head and neck cancer (HNC): an analysis of two Eastern Cooperative Oncology Group (ECOG) randomized trials. [Abstract] J Clin Onc

Argiris A, Li Y, Forastiere A. Prognostic factors and long-term survivorship in patients with recurrent or metastatic carcinoma of the head and neck. Cancer. 2004 Nov 15;101(10):2222-9. — View Citation

Gibson MK, Li Y, Murphy B, Hussain MH, DeConti RC, Ensley J, Forastiere AA; Eastern Cooperative Oncology Group. Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): an in — View Citation

Murphy B, Li Y, Cella D, et al.: Phase III study comparing cisplatin (C) & 5-flourouracil (F) versus cisplatin & paclitaxel (T) in metastatic/recurrent head & neck cancer (MHNC). [Abstract] Proceedings of the American Society of Clinical Oncology 20; A-89

Wells N, Murphy B, Dietrich M, et al.: Quality of life and pain assessment for head and neck cancer patients treated on E1395: a comparison of two different cisplatin-based chemotherapy regimens. [Abstract] Proceedings of the American Society of Clinical