Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer

Launched by NATIONAL CANCER INSTITUTE (NCI) · Mar 10, 2004

Keywords

ClinConnect Summary

OBJECTIVES:

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 patients.

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...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically proven non-small cell lung cancer
• • Eligible for chest irradiation with 3,000 to 6,000 cGy (based upon standard radiotherapy indications)
• • Measurable or evaluable disease
• • Measurable disease defined as bidimensionally measurable lesion on physical exam or radiograph (CT or MRI acceptable)
• PATIENT CHARACTERISTICS:
• • 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

Trial Officials