Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
- Conditions
- Head and Neck CancerLung Cancer
- Registration Number
- NCT00021333
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Southern Chester County Medical Center
🇺🇸West Grove, Pennsylvania, United States
Kimball Medical Center
🇺🇸Lakewood, New Jersey, United States
Hunterdon Regional Cancer Center
🇺🇸Flemington, New Jersey, United States
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Riverview Medical Center - Booker Cancer Center
🇺🇸Red Bank, New Jersey, United States
Pinnacle Health Hospitals
🇺🇸Harrisburg, Pennsylvania, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Bon Secours-Holy Family Health System
🇺🇸Altoona, Pennsylvania, United States
Saint Mary Regional Center
🇺🇸Langhorne, Pennsylvania, United States
Central Montgomery Medical Center
🇺🇸Lansdale, Pennsylvania, United States
Conemaugh Memorial Hospital
🇺🇸Johnstown, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Pottstown Memorial Regional Cancer Center
🇺🇸Pottstown, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States