Trial Information

Phase I/II Trial of the Combination of Docetaxel, Gemcitabine and Cisplatin (DGP) as Induction Chemotherapy in Patients With Stage III Non-Small Cell Lung Cancer

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and schedule of docetaxel,
gemcitabine, and cisplatin as induction chemotherapy in patients with Stage III non-small
cell lung cancer (NSCLC) scheduled to undergo subsequent surgical resection or irradiation.
II. Determine the major objective response rate of this combination therapy in these
patients.

OUTLINE: This is a dose escalation study. Docetaxel in administered as a 1 hour IV infusion
at week 1, 5, and 9. Gemcitabine is administered as a 30 minute IV infusion at weeks 1, 2,
3, 5, 6, 7, 9, 10, and 11. Cisplatin is administered as a 20 minute IV infusion at weeks 3,
7, and 11. In addition, G-CSF is administered subcutaneously on days 2 through 6 of each 28
day cycle following each dose of docetaxel. Three patients are entered at each dose level
and must complete one cycle of therapy. If no patient experiences dose limiting toxicity
(DLT), then 3 patients are treated at the next higher dose level. If 1 patient experiences
DLT, then 3 more patients are treated at that same dose level. If 2 of 6 patients experience
DLT, then that dose is declared the maximum tolerated dose (MTD). Once the MTD is
determined, the Phase II portion of the study begins and additional patients are treated at
the dose level just below the MTD. Patients who show complete or partial response, or no
change, after chemotherapy, undergo surgical resection or radiotherapy to remove or reduce
their tumor. Patients are assessed for disease progression and unacceptable toxicities every
4 weeks till end of treatment.

PROJECTED ACCRUAL: An estimated 40 patients will be accrued in this study.