A Phase II Trial of Induction Paclitaxel Plus Carboplatin Followed by Thoracic Radiation Therapy With Concurrent Weekly Low-Dose Paclitaxel and Twice Weekly Amifostine for Patients With Unresectable Locally Advanced or Partially Resected Non-Small Cell Lung Cancer
OBJECTIVES: I. Determine the toxic effects and antitumor efficacy of paclitaxel plus
carboplatin in patients with unresectable, intrathoracic non-small cell lung cancer (NSCLC).
II. Integrate concurrent thoracic radiation therapy and weekly low dose paclitaxel into
treatment of this patient population. III. Investigate a primary chemoradiotherapy treatment
approach in a population of patients selected on the basis of performance status regardless
of degree of weight loss. IV. Determine the effect of amifostine on the incidence of
treatment nonhematologic toxic effects, specifically esophagitis, pneumonitis, and radiation
dermatitis, in these patients.
OUTLINE: This is an open label study. Patients receive induction therapy comprising
paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on days 1 and 21. Patients
then undergo radiotherapy beginning on day 42 (or no later than day 63) daily 5 days a week
for 7 weeks. Patients also receive amifostine IV over 15 minutes followed by paclitaxel IV
over 3 hours weekly (day 1 each week) concurrently for the duration of radiotherapy. On 2
other days of the week, patients receive amifostine alone preceding thoracic radiotherapy.
Patients are followed every 3 months for 1 year and then every 6 months until disease
progression or death.
PROJECTED ACCRUAL: Approximately 15-35 patients will be accrued for this study.
Primary Purpose: Treatment
Maria Werner-Wasik, MD
Kimmel Cancer Center (KCC)
United States: Federal Government
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|