Alternating Phase I/II Trials of Twice-Weekly Infusion Gemcitabine (2'2'-Difluoro-2'-Deoxycytidine) and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of Cisplatin/Gemcitabine Induction Chemotherapy for the Treatment of Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
- Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered
concurrently with thoracic radiotherapy alone or following 2 cycles of induction
chemotherapy in patients with Stage IIIA or IIIB non-small cell lung cancer.
- Assess the toxicity of concurrent thoracic radiation and gemcitabine in these patients.
- Determine the effectiveness of concurrent radiation and gemcitabine by determining the
complete response rate, partial response rate, time to recurrence, pattern of
recurrence, and overall survival in a cohort of these patients.
OUTLINE: This is an alternating two arm, dose escalation, multicenter study.
Arm I: Patients receive twice-weekly gemcitabine as a 30 minute infusion. Concurrent
radiation therapy is administered 5 days a week for 6 weeks.
Arm II: Patients receive 2 cycles of induction chemotherapy consisting of gemcitabine as a
30 minute infusion on day 1 and 8 and cisplatin IV over 1 hour on day 1. Each cycle is 21
days. Patients then receive gemcitabine and radiation therapy as in arm I.
Cohorts of 3 patients are enrolled into each treatment arm at each dose level of
gemcitabine. Toxicity for each arm is assessed independently. Once dose limiting toxicity
(DLT) is observed at any dose level, 3 more patients are enrolled at the same dose level.
The maximum tolerated dose (MTD) is defined as the dose at which no more than 1 of 6
patients experiences grade 4 toxicity, or no more than 4 of 6 patients experience grade 3 or
worse toxicity (DLT). After the MTD is determined for each treatment arm, additional
patients are treated at that dose level for the phase II portion of the study.
Patients are followed every 3 months for 2 years, then every 4 months for the next 2 years,
and then every 6 months thereafter.
PROJECTED ACCRUAL: There will be approximately 24-48 patients accrued into this study within
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
•Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy
Arthur William Blackstock, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|