Phase I trial to study the effectiveness of radiation therapy plus topotecan in treating
patients who have non-small cell lung cancer. Drugs used in chemotherapy use different ways
to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and
radiation therapy may kill more tumor cells.
I. Determine the maximum tolerated dose of topotecan and chest irradiation in patients with
non-small cell lung cancer.
II. Determine the qualitative and quantitative toxic effects of this regimen in these
III. Determine the degree of antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation study of topotecan and thoracic radiotherapy.
Beginning on day 1, patients receive topotecan IV continuously for 3-6 weeks and thoracic
radiotherapy 5 days a week for 2, 3, or 6 weeks. Cohorts of 4-6 patients receive escalating
doses of topotecan and thoracic radiotherapy until the maximum tolerated dose (MTD) of each
therapy is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6
patients experience dose-limiting toxicity. Six additional patients are treated at the MTD.
Patients who fail to achieve complete remission (CR) and continue to have measurable disease
at 4-6 weeks after completion of radiotherapy receive topotecan IV continuously on days 1-21
at 1 dose level preceding the MTD as determined by the ongoing Protocol NYU-9123. Treatment
continues every 4 weeks in the absence of unacceptable toxicity.
- Histologically proven non-small cell lung cancer
- Eligible for chest irradiation with 3,000 to 6,000 cGy (based upon standard
- Measurable or evaluable disease
- Measurable disease defined as bidimensionally measurable lesion on physical exam or
radiograph (CT or MRI acceptable)
- Age: 18 and over
- Performance status: 0-2
- Life expectancy: At least 12 weeks
- WBC at least 4,000/mm3
- Platelet count at least 100,000/mm3
- Bilirubin no greater than 1.5 mg/dL
- AST less than 3 times normal
- Alkaline phosphatase less than 3 times normal
- Creatinine no greater than 1.5 mg/dL
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- No more than 1 prior chemotherapy regimen allowed
- At least 4 weeks since prior chemotherapy and recovered
- No prior radiotherapy
- Recovered from toxic effects of any prior therapy