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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057473
Recruitment Status : Completed
First Posted : April 3, 2003
Last Update Posted : April 14, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: carboplatin + irinotecan Drug: irinotecan Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

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 Name: 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.

Primary Outcome Measures :
  1. estimate response rate

Secondary Outcome Measures :
  1. evaluate safety

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057473

United States, Florida
Local Institution
Orlando, Florida, United States
United States, Texas
Local Institution
Houston, Texas, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information: Identifier: NCT00057473     History of Changes
Other Study ID Numbers: CA124-002
First Posted: April 3, 2003    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by Bristol-Myers Squibb:
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action