Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer

NCT00005035 | Completed Phase 2

• 3 other identifiers: CDR0000067571OSU-99H0309NCI-T99-0016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 11

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.

Conditions

Head and Neck Cancer

Keywords

metastatic squamous neck cancer with occult primary squamous cell carcinoma; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Interventions

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

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

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

Saint Joseph's Regional Medical Center

South Bend, Indiana, 46634-1935, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Chris A. Rhoades, MD

  Ohio State University Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: March 4, 2004
• Study Start: December 1, 1999
• Study Completion: March 1, 2004
• Last Updated: January 31, 2013

Record last verified: 2002-02

Locations

US (11)