Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	Other	JMTO-LC03-03 NCT00132054

Objectives

Primary

1. 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

1. Determine the response rate in patients treated with this regimen.
2. Determine the overall survival of patients treated with this regimen.
3. Determine the frequency and severity of adverse events in patients treated with this regimen.

Entry 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

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/m², or epirubicin ≥ 900 mg/m²)

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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 (PaO₂) ≥ 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

Expected Enrollment

A total of 6-30 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Japan and Multinational Clinical Trial Organization

Tadashi Mio, MD, Protocol chair		Ph: 81-75-751-3830 Email: mio@kuhp.kyoto-u.ac.jp

Registry Information
Official Title		Phase I Study of Weekly Irinotecan Combined with Amrubicin in Previously Treated Small-Cell Lung Cancer
Trial Start Date		2004-05-01
Trial Completion Date		2006-12-21
Registered in ClinicalTrials.gov		NCT00132054
Date Submitted to PDQ		2005-06-28
Information Last Verified		2006-12-03