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Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003264
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin plus gemcitabine in treating patients with advanced squamous cell head and neck cancer that cannot be treated by surgery or radiation therapy.


Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Head and Neck Cancer    Salivary Gland Disorders   

Drug Information available for:   Cisplatin    Gemcitabine hydrochloride    Gemcitabine    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced (Recurrent or Metastatic) Carcinoma of the Head and Neck

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

Estimated Enrollment:   36
Study Start Date:   October 1997

Detailed Description:

OBJECTIVES: I. Evaluate the response rate and toxicity of weekly cisplatin and gemcitabine in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who have received either no prior chemotherapy or no more than one prior chemotherapy regimen for advanced disease.

OUTLINE: Patients are stratified according to prior chemotherapy status: chemotherapy naive (no prior chemotherapy, or prior neoadjuvant or adjuvant chemotherapy at least 6 months prior to recurrence, or prior biologic agents only) vs chemotherapy exposed (one prior chemotherapy regimen directed at recurrent or newly diagnosed metastatic disease and/or prior neoadjuvant or adjuvant chemotherapy less than 6 months prior to recurrence). Patients receive gemcitabine as a 30 minute infusion weekly for 3 weeks followed by one week of rest. Cisplatin is administered as a 30-60 minute infusion immediately preceding gemcitabine. Treatment repeats every 28 days for 2-6 courses, depending on response. Patients with previously untreated metastatic disease may have treatment interrupted to receive radiation therapy to locoregional disease sites. Patients may continue treatment beyond 6 courses at the discretion of the physician. Patients are followed every 3 months.

PROJECTED ACCRUAL: This study will accrue approximately 36 patients.

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

Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck considered incurable with surgery or radiation therapy Bidimensionally measurable disease or readily evaluable disease by either physical exam or radiography Biopsy proven recurrence following completion of radiotherapy required if only site of measurable disease is within a previous radiation port

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Neurologic: Peripheral sensory neuropathy no greater than grade 1 Other: No significant active infection (patients with WBC of 12,000/mm3 or greater, or fever of 100.6 degrees F or higher, must be evaluated to rule out occult infection) Not pregnant or nursing Effective contraception required of fertile patients No active second malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy (interleukin-2, interferon, monoclonal antibodies, and/or retinoids) permitted Recovered from prior biologic therapy Chemotherapy: No more than one prior chemotherapy regimen for advanced or relapsed disease No chemotherapy within 4 weeks prior to study Prior neoadjuvant or radiosensitizing chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy permitted Recovered from prior radiotherapy Surgery: Recovered from major surgery

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003264

Locations
United States, New Jersey
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County    
      Mount Holly, New Jersey, United States, 08060
Hunterdon Regional Cancer Center    
      Flemington, New Jersey, United States, 08822
Riverview Medical Center - Booker Cancer Center    
      Red Bank, New Jersey, United States, 07701
St. Francis Medical Center    
      Trenton, New Jersey, United States, 08629
United States, Pennsylvania
Delaware County Memorial Hospital    
      Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111
St. Luke's Network - Bethlehem    
      Bethlehem, Pennsylvania, United States, 18015
North Penn Hospital    
      Lansdale, Pennsylvania, United States, 19446-1200
Paoli Memorial Hospital    
      Paoli, Pennsylvania, United States, 19301-1792
Reading Hospital and Medical Center    
      Reading, Pennsylvania, United States, 19612-6052
Saint Mary Regional Center    
      Langhorne, Pennsylvania, United States, 19047
Harrisburg Polyclinic Medical Center    
      Harrisburg, Pennsylvania, United States, 17101

Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Corey J. Langer, MD     Fox Chase Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000066159, FCCC-97021, NCI-G98-1403
First Received:   November 1, 1999
Last Updated:   October 12, 2008
ClinicalTrials.gov Identifier:   NCT00003264
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV salivary gland cancer  
recurrent salivary gland cancer  
recurrent metastatic squamous neck cancer with occult primary  
metastatic squamous neck cancer with occult primary squamous cell carcinoma  
salivary gland squamous cell carcinoma  
stage IV squamous cell carcinoma of the lip and oral cavity  
recurrent squamous cell carcinoma of the lip and oral cavity  
stage IV squamous cell carcinoma of the oropharynx  
recurrent squamous cell carcinoma of the oropharynx  
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
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
Nasopharyngeal carcinoma
Cisplatin
Head and Neck Neoplasms
Metastatic squamous neck cancer with occult primary
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Gemcitabine
Salivary Gland Diseases

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2008




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