Lung Cancer Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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