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
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.
Interventional
Primary Purpose: Treatment
Corey J. Langer, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000068770
NCT00021333
September 1999
May 2008
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Community Medical Center | Toms River, New Jersey 08755 |
St. Francis Medical Center | Trenton, New Jersey 08629 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
South Jersey Regional Cancer Center | Millville, New Jersey 08332 |
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly, New Jersey 08060 |
Hunterdon Regional Cancer Center | Flemington, New Jersey 08822 |
Kimball Medical Center | Lakewood, New Jersey 08701 |
Riverview Medical Center - Booker Cancer Center | Red Bank, New Jersey 07701 |
Saint Mary Regional Center | Langhorne, Pennsylvania 19047 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Pinnacle Health Hospitals | Harrisburg, Pennsylvania 17105-8700 |
Conemaugh Memorial Hospital | Johnstown, Pennsylvania 15905 |
Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania 19464 |
Bon Secours-Holy Family Health System | Altoona, Pennsylvania 16602 |
Central Montgomery Medical Center | Lansdale, Pennsylvania 19446-1200 |
Southern Chester County Medical Center | West Grove, Pennsylvania 19390 |