RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy with
docetaxel, gemcitabine, and cisplatin as induction therapy in treating 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
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.
DISEASE CHARACTERISTICS: Histologically confirmed Stage III (T1-2 N2-3 M0, T3 N2 M0, or T4
N0-3 M0) non-small cell lung cancer Must be candidates for either a resection with
curative intent or definitive thoracic irradiation following induction chemotherapy No
malignant pericardial or pleural effusions or superior vena cava syndrome Must have
measurable or evaluable indicator lesions
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100%
Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 160,000/mm3 Hepatic:
Bilirubin no greater than 1.0 mg/dL SGOT and/or SGPT no greater than 1.5 times the upper
limit of normal Alkaline phosphatase no greater than 5 times the upper limit of normal
Renal: Creatinine clearance at least 65 mL/min Cardiovascular: Must have stable heart
rhythm No unstable angina No myocardial infarction within 6 months No clinical evidence of
congestive heart failure Neurologic: Must have normal auditory function No symptoms of
peripheral neuropathy Other: No prior malignancy except non-melanoma skin cancer or in
situ carcinoma of the cervix Not pregnant Adequate contraception required of all fertile
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy
Surgery: Not specified