search
Back to results

Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
carboplatin
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

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 Newly diagnosed, treatment-naive disease At least 1 unidimensionally measurable lesion No massive pleural or pericardial effusion by chest CT scan Manageable effusions allowed PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic WBC ≥ 3,000/mm^3 Absolute granulocyte count ≥ 1,500/mm^3 Hemoglobin ≥ 9.0 g/dL Hepatic ALT or AST ≤ 2 times upper limit of normal Bilirubin ≤ 1.5 mg/dL Renal Creatinine normal Cardiovascular No myocardial infarction within the past year No uncontrolled hypertension No unstable angina No congestive heart failure No ventricular arrhythmia requiring medical intervention No other serious cardiovascular disease Pulmonary Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg No interstitial pneumonitis or pulmonary fibrosis by chest x-ray Other Not pregnant or nursing No uncontrolled diabetes No severe infection No paralytic or obstructive ileus No serious diarrhea No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the chest Other prior radiotherapy allowed Surgery At least 2 weeks since prior surgery and recovered

Sites / Locations

  • National Hospital Organization - Dohoku National Hospital
  • Fujisawa City Hospital
  • Kurashiki Central Hospital
  • Osaka General Medical Center
  • National Hospital Organization - Osaka National Hospital
  • Takatsuki Red Cross Hospital
  • Yao Tokusyu-kai General Hospital
  • Gunma Cancer Center
  • National Hospital Organization - Medical Center of Kure
  • Osaka Kosei Nenkin Hospital
  • Tokyo Medical and Dental University

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Survival
Progression-free survival

Full Information

First Posted
March 3, 2005
Last Updated
May 29, 2013
Sponsor
Japan Multinational Trial Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT00104793
Brief Title
Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
Official Title
Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
February 2007 (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 irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.
Detailed Description
OBJECTIVES: Primary Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin. Secondary Determine the progression-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses. PROJECTED ACCRUAL: A total of 55 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Primary Outcome Measure Information:
Title
Response
Secondary Outcome Measure Information:
Title
Survival
Title
Progression-free survival

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 Newly diagnosed, treatment-naive disease At least 1 unidimensionally measurable lesion No massive pleural or pericardial effusion by chest CT scan Manageable effusions allowed PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic WBC ≥ 3,000/mm^3 Absolute granulocyte count ≥ 1,500/mm^3 Hemoglobin ≥ 9.0 g/dL Hepatic ALT or AST ≤ 2 times upper limit of normal Bilirubin ≤ 1.5 mg/dL Renal Creatinine normal Cardiovascular No myocardial infarction within the past year No uncontrolled hypertension No unstable angina No congestive heart failure No ventricular arrhythmia requiring medical intervention No other serious cardiovascular disease Pulmonary Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg No interstitial pneumonitis or pulmonary fibrosis by chest x-ray Other Not pregnant or nursing No uncontrolled diabetes No severe infection No paralytic or obstructive ileus No serious diarrhea No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the chest Other prior radiotherapy allowed Surgery At least 2 weeks since prior surgery and recovered
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
National Hospital Organization - Dohoku National Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-0901
Country
Japan
Facility Name
Fujisawa City Hospital
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
558-0056
Country
Japan
Facility Name
National Hospital Organization - Osaka National Hospital
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Takatsuki Red Cross Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1096
Country
Japan
Facility Name
Yao Tokusyu-kai General Hospital
City
Yao
State/Province
Osaka
ZIP/Postal Code
561-0072
Country
Japan
Facility Name
Gunma Cancer Center
City
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
National Hospital Organization - Medical Center of Kure
City
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
Osaka Kosei Nenkin Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Facility Name
Tokyo Medical and Dental University
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22430871
Citation
Okishio K, Mio T, Kawahara M, Yoshioka H, Yanagihara K, Daimon T, Furuse K. A weekly combination of carboplatin and irinotecan for previously untreated extensive disease small-cell lung cancer, results of a minimum follow-up of 3 years: a multi-center Phase II trial JMTO LC02-02. Jpn J Clin Oncol. 2012 May;42(5):387-93. doi: 10.1093/jjco/hys028. Epub 2012 Mar 19.
Results Reference
result

Learn more about this trial

Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer

We'll reach out to this number within 24 hrs