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Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Clinical research trials and Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer. Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer clinical trial. Participants frequently get the best healthcare available for their Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
For Condition: lip and oral cavity cancer,Oropharyngeal Cancer,Head and Neck Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin alone for metastatic or recurrent head and neck cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin with or without monoclonal antibody in treating patients who have metastatic or recurrent head and neck cancer.
Details: OBJECTIVES: I. Compare the efficacy (survival and response rates) and toxicity of cisplatin with or without monoclonal antibody C225 in patients with metastatic and/or recurrent squamous cell head and neck cancer. II. Compare the correlation between epidermal growth factor receptor density and response and progression free survival in these patients. III. Determine the steady state serum levels of monoclonal antibody C225 and the frequency of human antibody response to this monoclonal antibody in patients treated with the combination therapy. PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified according to disease status (newly diagnosed vs recurrent) and ECOG status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive monoclonal antibody C225 IV over 2 hours followed 1 hour later by cisplatin IV over 2 hours on day 1 of course 1. Monoclonal antibody C225 is administered over 1 hour on subsequent courses. Arm II: Patients receive placebo IV over 2 hours followed 1 hour later by cisplatin as in arm I on day 1 of course 1. Placebo is administered over 1 hour on subsequent courses. Treatment continues every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Arm II patients who develop disease progression may then crossover to arm I treatment. Patients are followed at 1 and 3 months and then every 3 months until disease progression. PROJECTED ACCRUAL: A total of 114 patients will be accrued for this study within 14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven squamous cell carcinoma of the head and neck that is incurable with surgery or radiotherapy; No nasopharyngeal primaries - Measurable or evaluable disease - Newly diagnosed with extensive, incurable local regional disease AND distant metastases OR Local regional recurrence/persistence or distant metastases after surgery or radiotherapy; Persistent or progressive disease after radiotherapy must be histologically proven at least 8 weeks after therapy - No brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior chimeric antibody or kinase inhibitor for recurrent or metastatic disease; No more than 1 prior biotherapy regimen for recurrent or metastatic disease - Chemotherapy: At least 3 months since prior induction or adjuvant chemotherapy concurrent with radiotherapy; No prior chemotherapy for recurrent disease - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy - Surgery: See Disease Characteristics; Recovered from prior major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL (transfusion allowed) - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT and SGPT no greater than 2 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2 times ULN - Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine clearance at least 50 mL/min; Calcium no greater than ULN; No history of hypercalcemia - Other: No active infection; No other concurrent malignancy within past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; No known hypersensitivity to murine proteins; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraBurtness, Study Chair, Eastern Cooperative Oncology Group
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102-1192
United States
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, 17033
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
Pretoria Academic Hospitals
Pretoria, , 0001
South Africa
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, 80209-5031
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Veterans Affairs Medical Center - Nashville
Nashville, Tennessee, 37212
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Sooner State
Tulsa, Oklahoma, 74136
United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, 15240
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
United States
Veterans Affairs Medical Center - San Juan
San Juan, , 00927-5800
Puerto Rico
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Veterans Affairs Medical Center - Gainsville
Gainesville, Florida, 32608-1197
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Veterans Affairs Medical Center - Cleveland
Cleveland, Ohio, 44106
United States
Veterans Affairs Medical Center - New York
New York City, New York, 10010
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
MBCCOP - San Juan
San Juan, , 00927-5800
Puerto Rico
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Riverview Medical Center
Red Bank, New Jersey, 07701
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, 33612
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Additional Information:
Study ID Numbers: CDR0000066954; E-5397
Study Start Date: June 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003809
Other Head And Neck Cancer Studies:
1. Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
2. Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
3. Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer
4. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
5. Celecoxib in Treating Patients With Precancerous Lesions of the Mouth
Related Studies:
Other Head and Neck Cancer Clinical Trials
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Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
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