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

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00104793
• Lead Sponsor: Japan Multinational Trial Organization

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-03-03
• Study First Submitted QC: 2005-03-03
• Study First Posted: 2005-03-04
• Primary Completion: 2007-02
• Status Verified: 2007-10
• Study Completion: 2008-11
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response

Secondary Outcome Measures

Name	Time	Method
Survival
Progression-free survival

Trial Locations

Locations (11)

National Hospital Organization - Medical Center of Kure; 🇯🇵 Hiroshima, Japan

Tokyo Medical and Dental University; 🇯🇵 Tokyo, Japan

Fujisawa City Hospital; 🇯🇵 Fujisawa, Kanagawa, Japan

Osaka General Medical Center; 🇯🇵 Osaka-shi, Osaka, Japan

National Hospital Organization - Osaka National Hospital; 🇯🇵 Sakai, Osaka, Japan

Gunma Cancer Center; 🇯🇵 Gunma, Japan

Takatsuki Red Cross Hospital; 🇯🇵 Takatsuki, Osaka, Japan

Yao Tokusyu-kai General Hospital; 🇯🇵 Yao, Osaka, Japan

Osaka Kosei Nenkin Hospital; 🇯🇵 Osaka, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki-shi, Okayama, Japan

National Hospital Organization - Dohoku National Hospital; 🇯🇵 Asahikawa, Hokkaido, Japan