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Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy Clinical research trials and Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy. Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy  Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy
Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy
For Condition: Throat Cancer,Nose Cancer,Oral Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven metastatic or recurrent squamous cell carcinoma of the head and neck; Failure to respond to initial treatment with cisplatin and paclitaxel or cisplatin and fluorouracil - Bidimensionally measurable disease - Sufficient tumor tissue available for immunohistochemical determination of epidermal growth factor receptor expression - No meningeal or CNS involvement by tumor --Prior/Concurrent Therapy-- - Biologic therapy: No prior murine monoclonal antibody therapy or cetuximab - Chemotherapy: See Disease Characteristics; More than 1 year since prior chemotherapy and recovered; Cumulative total dose of prior platinum therapy no greater than 200 mg/m2; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 2 months since prior radiotherapy (1 month if disease progression occurred during radiotherapy); No concurrent radiotherapy - Surgery: At least 2 months since prior surgery except diagnostic biopsy - Other: At least 1 month since prior investigational agent --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; WBC at least 3,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN; AST and ALT no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance at least 60 mL/min - Cardiovascular: No history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities - Neurologic: No uncontrolled seizure disorder; No active neurologic disease; No neuropathy greater than grade 1 - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FairoozKabbinavar, Study Chair, Jonsson Comprehensive Cancer Center
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
Cooper Cancer Institute
Camden, New Jersey, 08103
United States
Monmouth Medical Center
Long Branch, New Jersey, 07740
United States
ImClone Systems, Incorporated
Somerville, New Jersey, 08876
United States
Additional Information:
Study ID Numbers: CDR0000067521; UCLA-9906095,NCI-G00-1667,IMCL-CP02-9816,UAB-9917
Study Start Date: November 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004865
Other Oral Cancer Studies:
1. Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy
2. Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer
3. Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
4. Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer
5. ZD1839 in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck
Related Studies:
Other Oral Cancer Clinical Trials
Other New Jersey Clinical Trials
Other Long Branch Clinical Trials
Cetuximab Plus Cisplatin in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck That Has Not Responded to Cisplatin Chemotherapy
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