Viewing Study NCT00104793



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Last Modification Date: 2024-10-26 @ 9:11 AM
Study NCT ID: NCT00104793
Status: COMPLETED
Last Update Posted: 2013-05-30
First Post: 2005-03-03

Brief Title: Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
Sponsor: Japan Multinational Trial Organization
Organization: National Cancer Institute NCI

Study Overview

Official Title: Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer
Status: COMPLETED
Status Verified Date: 2007-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
CDR0000415703 REGISTRY PDQ Physician Data Query None