Head and Neck Cancer Clinical Trial
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
Verified date | March 2009 |
Source | National Cancer Institute (NCI) |
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. 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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | January 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 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 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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cooper Cancer Institute | Camden | New Jersey |
United States | Kimball Medical Center | Lakewood | New Jersey |
United States | Monmouth Medical Center | Long Branch | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Jonsson Comprehensive Cancer Center | ImClone LLC, National Cancer Institute (NCI) |
United States,
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