Amrubicin and Irinotecan in Treating Patients With Recurrent or Relapsed Extensive Stage Small Cell Lung Cancer

Phase 1CompletedNCT00132054

Japan Multinational Trial Organization30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Lung Cancer

Interventions

amrubicin hydrochlorideDRUG

irinotecan hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Gunma Cancer Center

Gunma, Japan

National Hospital Organization - Dohoku National Hospital

Hokkaido, Japan

Kyoto University Hospital

Kyoto, Japan

Kitano Hospital

Osaka, Japan

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.