Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin. Secondary Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Official Title
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Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer Extensive stage disease Newly diagnosed, treatment-naive disease At least 1 unidimensionally measurable lesion No massive pleural or pericardial effusion by chest CT scan Manageable effusions allowed PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic WBC ≥ 3,000/mm^3 Absolute granulocyte count ≥ 1,500/mm^3 Hemoglobin ≥ 9.0 g/dL Hepatic ALT or AST ≤ 2 times upper limit of normal Bilirubin ≤ 1.5 mg/dL Renal Creatinine normal Cardiovascular No myocardial infarction within the past year No uncontrolled hypertension No unstable angina No congestive heart failure No ventricular arrhythmia requiring medical intervention No other serious cardiovascular disease Pulmonary Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg No interstitial pneumonitis or pulmonary fibrosis by chest x-ray Other Not pregnant or nursing No uncontrolled diabetes No severe infection No paralytic or obstructive ileus No serious diarrhea No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the chest Other prior radiotherapy allowed Surgery At least 2 weeks since prior surgery and recovered

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: irinotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 
| Progression-free survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extensive stage small cell lung cancer