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

April 7, 2011 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States
        • Local Institution
    • Texas
      • Houston, Texas, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • children 1-21 years of age
  • confirmed diagnosis of measurable solid tumor, including brain tumor, which has progressed on or after standard therapy, or for which no effective standard therapy is known
  • at least 4 weeks since last dose of immunotherapy, radiotherapy, or chemotherapy
  • no more than 3 prior chemotherapies
  • no symptomatic brain metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: carboplatin + irinotecan
Solution, IV, Carbopaltin AUC 4 mg/ml.min every 21 days; irinotecan 12 mg/m2/day x 10 days , Minimum of two cycles of chemotherapy projected to be up to 6.
Other Names:
  • Paraplatin
Active Comparator: Arm B
Drug: irinotecan
Solution, IV, irinotecan 12 mg/m2/day x 10 days, minimum of two cycles of chemotherapy projected to be up to 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
estimate response rate

Secondary Outcome Measures

Outcome Measure
evaluate safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

April 2, 2003

First Submitted That Met QC Criteria

April 2, 2003

First Posted (Estimate)

April 3, 2003

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA124-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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