Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00005035

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: oxaliplatin	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Oxaliplatin in Patients With Advanced Carcinoma of the Head and Neck

Study Start Date :

Dec 1, 1999

Actual Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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)

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
2	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
3	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
4	Evanston Northwestern Health Care	Evanston	Illinois	United States	60201
5	Lutheran General Cancer Care Center	Park Ridge	Illinois	United States	60068
6	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois	United States	61602
7	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62701
8	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	United States	46885-5099
9	Saint Joseph's Regional Medical Center	South Bend	Indiana	United States	46634-1935
10	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
11	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29605