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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 Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer Clinical research trials and Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer. Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer  Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
For Condition: Salivary Gland Cancer,Head and Neck Cancer,Oropharyngeal Cancer,lip and oral cavity cancer,Thyroid Cancer,Lung Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CoreyLanger, Study Chair, Fox Chase Cancer Center
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
United States
Central Montgomery Medical Center
Lansdale, Pennsylvania, 19446-1200
United States
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, 07701
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
United States
Saint Mary Regional Center
Langhorne, Pennsylvania, 19047
United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
United States
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Southern Chester County Medical Center
West Grove, Pennsylvania, 19390
United States
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
United States
Additional Information:
Study ID Numbers: CDR0000068770; NCI-G01-1983,FCCC-99025
Study Start Date: September 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021333
Other Lung Cancer Studies:
1. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
2. Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
3. BMS-247550 Plus Cisplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
4. Biological Therapy in Treating Patients With Metastatic Cancer
5. Gemcitabine in Treating Patients With Advanced Salivary Gland Cancer That Cannot Be Removed During Surgery
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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
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