Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC
- Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA
non-small cell lung cancer.
- Investigate the phenotypic changes induced in the tumor by this treatment.
OUTLINE: Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30
minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 3 courses until
disease progression. Once potential candidates for resectability are determined, patients
undergo thoracotomy or concurrent chemotherapy/radiation therapy within 6 weeks of
completing the last course of chemotherapy. Following resection, patients responding to
chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours.
Patients may undergo local irradiation beginning with the second course of carboplatin and
paclitaxel. Chemotherapy ceases if disease remains stable after 8 weeks.
Patients are followed every 3 months for the first year after treatment, then every 6 months
thereafter for survival.
PROJECTED ACCRUAL: This study will accrue 20 patients over 18 months.
Primary Purpose: Treatment
John R. Murren, MD
United States: Federal Government
|Yale Comprehensive Cancer Center
|New Haven, Connecticut 06520-8028