Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cetuximab plus cisplatin in treating patients who have metastatic or recurrent cancer of the head and neck that has not responded to previous cisplatin-based chemotherapy.
Head and Neck Cancer
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Cetuximab Anti-Epidermal Growth Factor Receptor (EGFr) Antibody in Combination With Chemotherapy in Patients With Metastatic or Recurrent Squamous Cell Head and Neck Carcinoma|
|Study Start Date:||November 1999|
|Primary Completion Date:||January 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the response rate, duration of response, and survival in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with cetuximab and cisplatin after failure of an initial cisplatin-based chemotherapy regimen. II. Determine the efficacy, safety, and toxicity of this regimen in these patients. III. Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study. Part I (courses 1 and 2): Patients are assigned to 1 of 2 treatment groups based on prior cisplatin-based chemotherapy regimen: Group 1 (prior cisplatin with paclitaxel): Patients receive cisplatin IV over 1 hour on day 1 and fluorouracil IV continuously on days 1-4. Group 2 (prior cisplatin with fluorouracil): Patients receive cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Both groups: Treatment repeats every 3 weeks for 2 courses. Patients who achieve partial or complete response after completion of course 2 are taken off study. Patients with stable disease or disease progression after completion of course 2 proceed to part II of the study. Part II (courses 3-6): Patients are stratified by response to initial cisplatin-based chemotherapy regimen (stable disease vs disease progression). Patients receive a test dose of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose. Patients receive cisplatin IV over 1 hour beginning 1 hour after completion of cetuximab infusion on day 1. Patients receive maintenance cetuximab IV over 1 hour on day 8. Maintenance cetuximab repeats weekly. Combination treatment repeats every 3 weeks for a maximum of 4 courses. Patients with stable or responding disease after completion of course 6 may continue to receive cetuximab alone in the absence of disease progression and at the discretion of the protocol investigator and sponsor. Quality of life is assessed before course 1, at the completion of courses 2, 4, and 6, and then at 4 weeks after completion of study. Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 175 patients will be accrued for this study within 8 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004865
|United States, New Jersey|
|Cooper Cancer Institute|
|Camden, New Jersey, United States, 08103|
|Kimball Medical Center|
|Lakewood, New Jersey, United States, 08701|
|Monmouth Medical Center|
|Long Branch, New Jersey, United States, 07740|
|Study Chair:||Fairooz F. Kabbinavar, MD||Jonsson Comprehensive Cancer Center|
|Investigator:||Paul Windt, PharmD||ImClone LLC|