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CompletedNCT00104793Updated May 30, 2013

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

A Phase 2 interventional study of carboplatin and irinotecan hydrochloride in Lung Cancer, sponsored by Japan Multinational Trial Organization. Completed at 11 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-30.

Sponsored by Japan Multinational Trial Organization · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

Keywords

  • extensive stage small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's planned enrollment of 55 is close to the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Japan Multinational Trial Organization is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
55 participants (estimated)

Interventions

  • Drugcarboplatin
  • Drugirinotecan hydrochloride
06

What researchers measure

Primary outcomes

  1. Response

Secondary outcomes

  1. Survival

  2. Progression-free survival

07

Study locations

11 sites
  • National Hospital Organization - Dohoku National Hospital
    Asahikawa, Hokkaido 070-0901, Japan
  • Fujisawa City Hospital
    Fujisawa, Kanagawa 251-8550, Japan
  • Kurashiki Central Hospital
    Kurashiki-shi, Okayama 710-8602, Japan
  • Osaka General Medical Center
    Osaka-shi, Osaka 558-0056, Japan
  • National Hospital Organization - Osaka National Hospital
    Sakai, Osaka 591-8555, Japan
  • Takatsuki Red Cross Hospital
    Takatsuki, Osaka 569-1096, Japan
  • Yao Tokusyu-kai General Hospital
    Yao, Osaka 561-0072, Japan
  • Gunma Cancer Center
    Gunma, 373-8550, Japan
  • National Hospital Organization - Medical Center of Kure
    Hiroshima, 737-0023, Japan
  • Osaka Kosei Nenkin Hospital
    Osaka, 553-0003, Japan
  • Tokyo Medical and Dental University
    Tokyo, 113-8519, Japan
08

References and documents

Publications

  • 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. PubMed 22430871 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00104793
Lead sponsor
Japan Multinational Trial Organization
First posted
Mar 4, 2005
Start date
Jun 2003
Primary completion
Feb 2007
Completion
Nov 2008
Last update
May 30, 2013

Study contacts

Tadashi Mio, MD
study chair · Kyoto University Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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