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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00104793
Recruitment Status : Completed
First Posted : March 4, 2005
Last Update Posted : May 30, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: irinotecan hydrochloride Phase 2

Detailed Description:



  • Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin.


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer
Study Start Date : June 2003
Actual Primary Completion Date : February 2007
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Response

Secondary Outcome Measures :
  1. Survival
  2. Progression-free survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • WBC ≥ 3,000/mm^3
  • Absolute granulocyte count ≥ 1,500/mm^3
  • Hemoglobin ≥ 9.0 g/dL


  • ALT or AST ≤ 2 times upper limit of normal
  • Bilirubin ≤ 1.5 mg/dL


  • Creatinine normal


  • 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


  • Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg
  • No interstitial pneumonitis or pulmonary fibrosis by chest x-ray


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • No prior radiotherapy to the chest

    • Other prior radiotherapy allowed


  • At least 2 weeks since prior surgery and recovered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00104793

National Hospital Organization - Dohoku National Hospital
Asahikawa, Hokkaido, Japan, 070-0901
Fujisawa City Hospital
Fujisawa, Kanagawa, Japan, 251-8550
Kurashiki Central Hospital
Kurashiki-shi, Okayama, Japan, 710-8602
Osaka General Medical Center
Osaka-shi, Osaka, Japan, 558-0056
National Hospital Organization - Osaka National Hospital
Sakai, Osaka, Japan, 591-8555
Takatsuki Red Cross Hospital
Takatsuki, Osaka, Japan, 569-1096
Yao Tokusyu-kai General Hospital
Yao, Osaka, Japan, 561-0072
Gunma Cancer Center
Gunma, Japan, 373-8550
National Hospital Organization - Medical Center of Kure
Hiroshima, Japan, 737-0023
Osaka Kosei Nenkin Hospital
Osaka, Japan, 553-0003
Tokyo Medical and Dental University
Tokyo, Japan, 113-8519
Sponsors and Collaborators
Japan Multinational Trial Organization
Study Chair: Tadashi Mio, MD Kyoto University

Publications of Results: Identifier: NCT00104793     History of Changes
Other Study ID Numbers: JMTO-LC02-02
CDR0000415703 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: October 2007

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action