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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
amrubicin hydrochloride
irinotecan hydrochloride
Sponsored by
Japan Multinational Trial Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, recurrent small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gunma Cancer Center
  • National Hospital Organization - Dohoku National Hospital
  • Kyoto University Hospital
  • Osaka Police Hospital
  • Kitano Hospital
  • Osaka Kosei Nenkin Hospital
  • National Hospital Organization - Osaka National Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 16, 2005
Last Updated
May 29, 2013
Sponsor
Japan Multinational Trial Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00132054
Brief Title
Amrubicin and Irinotecan in Treating Patients With Recurrent or Relapsed Extensive Stage Small Cell Lung Cancer
Official Title
Phase I Study of Weekly Irinotecan Combined With Amrubicin in Previously Treated Small-Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Multinational Trial Organization

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
amrubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tadashi Mio, MD
Organizational Affiliation
Kyoto University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Gunma Cancer Center
City
Gunma
ZIP/Postal Code
373-0828
Country
Japan
Facility Name
National Hospital Organization - Dohoku National Hospital
City
Hokkaido
ZIP/Postal Code
070-0901
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8501
Country
Japan
Facility Name
Osaka Police Hospital
City
Osaka City
ZIP/Postal Code
543-0035
Country
Japan
Facility Name
Kitano Hospital
City
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Facility Name
Osaka Kosei Nenkin Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
National Hospital Organization - Osaka National Hospital
City
Osaka
ZIP/Postal Code
591-8555
Country
Japan

12. IPD Sharing Statement

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

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