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Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung 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: NCT00021333
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may make tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation therapy followed by filgrastim in treating patients who have recurrent head and neck cancer or lung cancer.


Condition Intervention Phase
Head and Neck Cancer
Lung Cancer
Drug: cisplatin
Drug: filgrastim
Drug: paclitaxel
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Head and Neck Cancer    Lung Cancer   

Drug Information available for:   Filgrastim    Cisplatin    Paclitaxel    Sargramostim    Granulocyte-macrophage colony-stimulating factor    Granulocyte colony-stimulating factor    Thyroid    Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Evaluation Of Paclitaxel And Cisplatin In Combination With Split Course Hyperfractionated Radiation Therapy And Granulocyte-Colony Stimulating Factor In Previously Irradiated Patients With Locally Recurrent Carcinoma Of The Head And Neck, And Lung

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

Study Start Date:   September 1999

Detailed Description:

OBJECTIVES: I. Determine the response rate of patients with locally recurrent carcinoma of the head and neck or lung treated with paclitaxel and cisplatin with concurrent radiotherapy followed by filgrastim (G-CSF). II. Assess the toxicity of this regimen in these patients. III. Determine the time to progression and the sites and pattern of progression in patients treated with this regimen. IV. Determine the median, 1-year, and 2-year survival rates of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (squamous cell carcinoma of the head and neck vs salivary gland malignancy or other non-squamous cell carcinoma of the head and neck vs lung cancer). Patients receive paclitaxel IV over 1 hour and cisplatin IV over 30-120 minutes on days 1-5. Patients undergo radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously on days 6-13 or until blood counts recover. Treatment repeats every 2 weeks for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 42-84 patients (14-28 per stratum) will be accrued for this study within 2-4 years.

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

Criteria

DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Previously irradiated, locally recurrent squamous cell carcinoma of the head and neck (SCCHN) or head and neck skin/appendages with no distant metastases New second or subsequent primary SCCHN in a previously irradiated field with no distant metastases Salivary gland malignancy or other non-squamous cell primary head and neck cancer Previously irradiated, locally recurrent carcinoma of the lung No clinical evidence of symptomatic bone or brain metastases requiring radiotherapy No leptomeningeal metastases requiring intrathecal therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active, uncontrolled congestive heart failure or arrhythmia within the past 6 months Other: No pre-existing neuropathy grade 2 or greater interfering with daily activities No prior allergy to drugs using Cremophor EL No hypersensitivity to E. coli-derived proteins No significant concurrent medical or psychiatric disorder that would preclude study No other condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy Prior or concurrent cumulative radiotherapy dose to spinal cord no greater than 5,000 cGy Surgery: Not specified Other: Concurrent beta-blockers, digitalis derivatives, or calcium-channel blocking agents allowed if cardiac conditions are stable

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021333

Locations
United States, New Jersey
Community Medical Center    
      Toms River, New Jersey, United States, 08755
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
St. Francis Medical Center    
      Trenton, New Jersey, United States, 08629
Riverview Medical Center - Booker Cancer Center    
      Red Bank, New Jersey, United States, 07701
South Jersey Regional Cancer Center    
      Millville, New Jersey, United States, 08332
Kimball Medical Center    
      Lakewood, New Jersey, United States, 08701
United States, Pennsylvania
Bon Secours-Holy Family Health System    
      Altoona, Pennsylvania, United States, 16602
Central Montgomery Medical Center    
      Lansdale, Pennsylvania, United States, 19446-1200
Southern Chester County Medical Center    
      West Grove, Pennsylvania, United States, 19390
Delaware County Memorial Hospital    
      Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111
Paoli Memorial Hospital    
      Paoli, Pennsylvania, United States, 19301-1792
Pinnacle Health Hospitals    
      Harrisburg, Pennsylvania, United States, 17105-8700
Pottstown Memorial Regional Cancer Center    
      Pottstown, Pennsylvania, United States, 19464
Reading Hospital and Medical Center    
      Reading, Pennsylvania, United States, 19612-6052
Saint Mary Regional Center    
      Langhorne, Pennsylvania, United States, 19047
Conemaugh Memorial Hospital    
      Johnstown, Pennsylvania, United States, 15905

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:   CDR0000068770, FCCC-99025, NCI-G01-1983
First Received:   July 11, 2001
Last Updated:   October 12, 2008
ClinicalTrials.gov Identifier:   NCT00021333
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer  
recurrent small cell lung cancer  
recurrent thyroid cancer  
recurrent salivary gland cancer  
recurrent squamous cell carcinoma of the lip and oral cavity  
recurrent basal cell carcinoma of the lip  
recurrent verrucous carcinoma of the oral cavity  
recurrent mucoepidermoid carcinoma of the oral cavity  
recurrent adenoid cystic carcinoma of the oral cavity  
recurrent squamous cell carcinoma of the oropharynx  
recurrent lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity

Study placed in the following topic categories:
Thoracic Neoplasms
Squamous cell carcinoma
Sodium Salicylate
Adenoid cystic carcinoma
Cisplatin
Carcinoma, Adenoid Cystic
Respiratory Tract Diseases
Lung Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Papilloma
Salivary Gland Diseases
Non-small cell lung cancer
Thyroid Neoplasms
Salicylsalicylic acid
Carcinoma, Basal Cell
Granuloma
Recurrence
Carcinoma
Carcinoma, Small Cell
Epidermoid carcinoma
Nasopharyngeal carcinoma
Paclitaxel
Head and Neck Neoplasms
Lung Diseases
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 03, 2008




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