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

This study has been completed.

First Received on April 2, 2003. Last Updated on April 7, 2011 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00057473

Purpose

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	Intervention	Phase
Neoplasms	Drug: carboplatin + irinotecan Drug: irinotecan	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Irinotecan U 101440E Irinotecan hydrochloride

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

estimate response rate

Secondary Outcome Measures:

evaluate safety

Study Start Date:	February 2003
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	1 Year to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057473

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00057473 History of Changes
Other Study ID Numbers:	CA124-002
Study First Received:	April 2, 2003
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms
Irinotecan
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic

Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012