Amrubicin and Irinotecan in Treating Patients With Recurrent or Relapsed 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 amrubicin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of amrubicin when given together with irinotecan in treating patients with recurrent or relapsed extensive stage small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Determine the dose-limiting toxicity and maximum tolerated dose of amrubicin when combined with irinotecan in patients with recurrent or relapsed extensive stage small cell lung cancer. Secondary Determine the response rate in patients treated with this regimen. Determine the overall survival of patients treated with this regimen. Determine the frequency and severity of adverse events in patients treated with this regimen. OUTLINE: This is a dose-escalation study of amrubicin. Patients receive amrubicin on day 1 and irinotecan IV on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of up to 6 patients receive escalating doses of amrubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1/3 (or 33%) of patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD. PROJECTED ACCRUAL: A total of 6-30 patients will be accrued for this study.

Official Title
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Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: amrubicin hydrochloride
* 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 Recurrent or relapsed disease after 1-2 prior chemotherapy and/or radiotherapy regimens No unmanageable massive pleural effusion or pericardial effusion by chest CT scan No symptomatic brain metastasis PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.5 g/dL Hepatic ALT and AST ≤ 2 times upper limit of normal Bilirubin ≤ 1.5 mg/dL Renal Creatinine normal Cardiovascular No uncontrolled hypertension No unstable angina No congestive heart failure No myocardial infarction within the past year No ventricular arrhythmia requiring medical intervention No other serious cardiovascular disease Pulmonary Arterial oxygen pressure (PaO_2) ≥ 70 torr No interstitial pneumonitis or pulmonary fibrosis by chest x-ray Gastrointestinal No serious diarrhea No paralytic or obstructive ileus Other Not pregnant or nursing No uncontrolled diabetes No severe infectious disorder PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior anthracycline or its derivatives at > the upper dose limit (e.g., daunorubicin ≥ 25 mg/kg, doxorubicin ≥ 500 mg/m^2, or epirubicin ≥ 900 mg/m^2) Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery Not specified

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


Arms and Interventions

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

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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extensive stage small cell lung cancer, recurrent small cell lung cancer