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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132054
• Other study ID #: JMTO-LC03-03
• Secondary ID: CDR0000439464
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2005
• Last updated: May 29, 2013
• Start date: May 2004
• Est. completion date: November 2008

Study information

• Verified date: December 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• amrubicin hydrochloride

• irinotecan hydrochloride

Locations

Country	Name	City	State
Japan	Gunma Cancer Center	Gunma
Japan	National Hospital Organization - Dohoku National Hospital	Hokkaido
Japan	Kyoto University Hospital	Kyoto
Japan	Kitano Hospital	Osaka
Japan	National Hospital Organization - Osaka National Hospital	Osaka
Japan	Osaka Kosei Nenkin Hospital	Osaka
Japan	Osaka Police Hospital	Osaka City

Sponsors (1)

Lead Sponsor	Collaborator
Japan Multinational Trial Organization

Country where clinical trial is conducted

Japan,