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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Multinational Trial Organization
• Treatments: Amrubicin; Camptothecin; Irinotecan

Criteria

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