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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH CHEST IRRADIATION

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: topotecan hydrochloride
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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. | Drug: topotecan hydrochloride<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer