Phase II Randomized Study of Taxol (PACLITAXEL), Paraplatin (Carboplatin), and Radiation Therapy for Locally Advanced Inoperable Non-Small Cell Lung Cancer
OBJECTIVES: I. Compare survival of patients with stage IIIA or IIIB unresectable non-small
cell lung cancer treated with one of three different combined modality regimens of
paclitaxel, carboplatin, and radiotherapy. II. Compare the safety and toxicity of these
treatment regimens in these patients. III. Compare the relapse free survival rate in these
patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three
treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over
30 minutes on day 1 every 3 weeks for 2 courses, followed by radiotherapy 5 times a week for
7 weeks beginning on day 42. Arm II: Patients receive paclitaxel and carboplatin as in arm I
followed by radiotherapy 5 times a week, paclitaxel IV over 1 hour, and carboplatin IV over
30 minutes weekly for 7 weeks beginning on day 42. Arm III: Patients receive paclitaxel IV
over 1 hour and carboplatin IV over 30 minutes weekly and radiotherapy 5 times a week for 7
weeks beginning on day 1, followed by paclitaxel IV over 3 hours and carboplatin IV over 30
minutes every 3 weeks for 2 courses beginning 3 weeks after concurrent chemotherapy and
radiotherapy. Patients are followed every 3 months for 2 years, every 4 months for 2 years,
and then annually thereafter.
PROJECTED ACCRUAL: A total of 264 patients (88 per treatment arm) will be accrued for this
study within 20 months.
Interventional
Primary Purpose: Treatment
Nathan Levitan, MD
Study Chair
Case Comprehensive Cancer Center
United States: Federal Government
CDR0000068252
NCT00006378
December 1999
Name | Location |
---|---|
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |