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
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 |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | August 2004 |
Est. primary completion date | |
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 |
Allocation: Randomized, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI), Southwest Oncology Group |
United States,
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
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