Head and Neck Cancer Clinical Trial
Official title:
Phase II Study of C225 in Combination With Cisplatin and Standard/Delayed Accelerated Hyperfractionated Radiation Therapy in Patients With Advanced Head & Neck Cancer
Verified date | June 2013 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy
with monoclonal antibody therapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining cetuximab, cisplatin, and
radiation therapy in treating patients who have advanced stage III or stage IV head and neck
cancer.
Status | Completed |
Enrollment | 0 |
Est. completion date | October 2005 |
Est. primary completion date | October 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Newly diagnosed or recurrent, advanced stage III or IV squamous
cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or paranasal
sinus/nasal cavity M0 No nasopharyngeal cancer Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN Bilirubin no greater than 1.5 times ULN Renal: Creatinine no greater than 1 times ULN Creatinine clearance at least 60 mL/min Calcium no greater than 11.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No prior cetuximab No prior immunotherapy Chemotherapy: At least 3 years since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head or neck region No other concurrent radiotherapy Surgery: At least 60 days since prior surgery Diagnostic biopsy allowed |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI) |
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