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Home > "O" Clinical Trials Conditions > Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer  Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
For Condition: lip and oral cavity cancer,Oropharyngeal Cancer,Head and Neck Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have advanced head and neck cancer.
Details: OBJECTIVES: I. Determine the response rate of patients with advanced squamous cell carcinoma of the head and neck when treated with oxaliplatin. II. Characterize the toxicities and pharmacokinetics of this drug in this patient population. III. Determine the duration of response, time to progression, and survival of these patients receiving this drug. PROTOCOL OUTLINE: Patients are stratified according to prior treatment with neoadjuvant chemotherapy (yes vs no). Patients receive oxaliplatin IV over 2 hours weekly for 4 weeks followed by 2 weeks of rest. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed until toxicity resolves or for no less than 30 days. PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 17 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed squamous cell carcinoma of the head and neck; Recurrent or metastatic OR Locally advanced and judged incurable by surgery or radiotherapy - Bidimensionally measurable disease; New and unirradiated lesion within prior radiation field acceptable as measurable disease if at least 3 months since prior radiotherapy - No known brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy for head and neck cancer; No concurrent colony stimulating factors during first course of therapy - Chemotherapy: No prior chemotherapy for recurrent or metastatic disease; At least 3 months since prior chemotherapy as initial treatment - Endocrine therapy: No prior hormonal therapy for head and neck cancer - Radiotherapy: See Disease Characteristics; At least 3 months since prior radiotherapy as initial treatment - Surgery: See Disease Characteristics; Prior surgery allowed - Other: No other concurrent investigational or commercial agents or therapies --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 OR Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin normal; AST/ALT no greater than 2.5 times upper limit of normal - Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min - Cardiovascular: No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No evidence of neuropathy; No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol therapy; No other concurrent uncontrolled illness (e.g., ongoing or active infection); Not HIV positive AND receiving antiretroviral therapy (HAART)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChrisRhoades, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Saint Joseph's Regional Medical Center
South Bend, Indiana, 46634-1935
United States
Additional Information:
Study ID Numbers: CDR0000067571; OSU-99H0309,NCI-T99-0016
Study Start Date: December 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005035
Other Lip And Oral Cavity Cancer Studies:
1. Fruit and Vegetable Extracts in Treating Patients With Stage I, Stage II, or Stage III Head and Neck Cancer
2. Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
3. Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
4. Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer
5. Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
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Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
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