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
cetuximab
+ cisplatin
Carcinome+5
+ Carcinome à cellules squameuses
+ Néoplasmes
Étude thérapeutique
Résumé
Date de début de l'étude : 6 août 1999
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 120 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 76 sites
CCOP - Scottsdale Oncology Program
Scottsdale, United StatesOuvrir CCOP - Scottsdale Oncology Program dans Google MapsMayo Clinic Scottsdale
Scottsdale, United StatesBeckman Research Institute, City of Hope
Los Angeles, United StatesVeterans Affairs Medical Center - Palo Alto
Palo Alto, United States