A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid Tumors

Phase 2

Completed

• Conditions: Neoplasms
• Interventions: Drug: carboplatin + irinotecan; Drug: irinotecan

• Registration Number: NCT00057473
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

This clinical research study is being conducted to investigate the effectiveness of combining carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory solid tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-04-02
• Study First Submitted QC: 2003-04-02
• Study First Posted: 2003-04-03
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Disposition First Submitted: 2010-02-03
• Disposition First Submitted QC: 2010-02-03
• Disposition First Posted: 2010-02-05
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	carboplatin + irinotecan	-
Arm B	irinotecan	-

Primary Outcome Measures

Name	Time	Method
estimate response rate

Secondary Outcome Measures

Name	Time	Method
evaluate safety

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Houston, Texas, United States