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Randomized, Double Blind, Placebo Controlled Phase III Evaluation of Cisplatin + Placebo Versus Cisplatin + C225 a Mouse/Human Monoclonal Antibody to the Epidermal Growth Factor Receptor, in Patients With Metastatic and/or Recurrent Squamous Cell Cancer of the Head and Neck


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Randomized, Double Blind, Placebo Controlled Phase III Evaluation of Cisplatin + Placebo Versus Cisplatin + C225 a Mouse/Human Monoclonal Antibody to the Epidermal Growth Factor Receptor, in Patients With Metastatic and/or Recurrent Squamous Cell Cancer of the Head and Neck


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.

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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Barbara A. Burtness, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University

Authority:

United States: Federal Government

Study ID:

CDR0000066954

NCT ID:

NCT00003809

Start Date:

June 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • untreated metastatic squamous neck cancer with occult primary
  • recurrent metastatic squamous neck cancer with occult primary
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Stanford University Medical Center Stanford, California  94305-5408
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Johns Hopkins Oncology Center Baltimore, Maryland  21287
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
University of Rochester Cancer Center Rochester, New York  14642
Ireland Cancer Center Cleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Sylvester Cancer Center, University of Miami Miami, Florida  33136
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Colorado Cancer Research Program, Inc. Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
New England Medical Center Hospital Boston, Massachusetts  02111
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
CCOP - Duluth Duluth, Minnesota  55805
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Beckman Research Institute, City of Hope Los Angeles, California  91010
CCOP - Central Illinois Springfield, Illinois  62526
St. Francis Medical Center Trenton, New Jersey  08629
Veterans Affairs Medical Center - Albany Albany, New York  12208
CCOP - Columbus Columbus, Ohio  43206
Penn State Geisinger Cancer Center Hershey, Pennsylvania  17033
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Veterans Affairs Medical Center - New York New York, New York  10010
CCOP - Marshfield Medical Research and Education Foundation Marshfield, Wisconsin  54449
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Hackensack University Medical Center Hackensack, New Jersey  07601
Riverview Medical Center Red Bank, New Jersey  07701
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
Veterans Affairs Medical Center - Cleveland Cleveland, Ohio  44106
Veterans Affairs Medical Center - Nashville Nashville, Tennessee  37212
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
CCOP - Sooner State Tulsa, Oklahoma  74136
Veterans Affairs Medical Center - Gainsville Gainesville, Florida  32608-1197