Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Biological: cetuximab
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: cetuximab|nan|
|Drug: cisplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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, 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 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