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

Sponsor:	Japan Multinational Trial Organization
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00132054

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: amrubicin hydrochloride Drug: irinotecan hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Irinotecan U 101440E Amrubicin Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	30
Study Start Date:	May 2004
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132054

Locations

Japan
Gunma Cancer Center
Gunma, Japan, 373-0828
National Hospital Organization - Dohoku National Hospital
Hokkaido, Japan, 070-0901
Kyoto University Hospital
Kyoto, Japan, 606-8501
National Hospital Organization - Osaka National Hospital
Osaka, Japan, 591-8555
Osaka Kosei Nenkin Hospital
Osaka, Japan, 553-0003
Kitano Hospital
Osaka, Japan, 530-8480
Osaka Police Hospital
Osaka City, Japan, 543-0035

Sponsors and Collaborators

Japan Multinational Trial Organization

Investigators

Study Chair:

Tadashi Mio, MD

Kyoto University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00132054 History of Changes
Other Study ID Numbers:	CDR0000439464, JMTO-LC03-03
Study First Received:	August 16, 2005
Last Updated:	November 25, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Amrubicin
Irinotecan

Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012