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Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer

Phase 2
Completed
Conditions
Head and Neck Cancer
Registration Number
NCT00005035
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Brief Summary

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.

Detailed Description

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Lutheran General Cancer Care Center

🇺🇸

Park Ridge, Illinois, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Inc.

🇺🇸

Fort Wayne, Indiana, United States

Louis A. Weiss Memorial Hospital

🇺🇸

Chicago, Illinois, United States

Decatur Memorial Hospital Cancer Care Institute

🇺🇸

Decatur, Illinois, United States

Evanston Northwestern Health Care

🇺🇸

Evanston, Illinois, United States

Saint Joseph's Regional Medical Center

🇺🇸

South Bend, Indiana, United States

Arthur G. James Cancer Hospital - Ohio State University

🇺🇸

Columbus, Ohio, United States

Central Illinois Hematology Oncology Center

🇺🇸

Springfield, Illinois, United States

Oncology/Hematology Associates of Central Illinois, P.C.

🇺🇸

Peoria, Illinois, United States

Cancer Centers of the Carolinas

🇺🇸

Greenville, South Carolina, United States

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