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Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer

This study has been completed.

Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005035
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: oxaliplatin
Phase II

MedlinePlus related topics:   Cancer    Head and Neck Cancer   

Drug Information available for:   Oxaliplatin    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Study of Oxaliplatin in Patients With Advanced Carcinoma of the Head and Neck

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005035

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

Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Chris A. Rhoades, MD     Arthur G. James Cancer Hospital & Richard J. Solove Research Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067571, OSU-99H0309, NCI-T99-0016
First Received:   April 6, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005035
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Squamous cell carcinoma
Salicylsalicylic acid
Sodium Salicylate
Recurrence
Carcinoma
Epidermoid carcinoma
Oxaliplatin
Nasopharyngeal carcinoma
Head and Neck Neoplasms
Metastatic squamous neck cancer with occult primary
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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