Carboplatin and Irinotecan in Treating 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: NCT00024284
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 5, 2013
National Cancer Institute (NCI)
Information provided by:
Bristol-Myers Squibb

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and irinotecan in treating children who have refractory solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Childhood Solid Tumor, Protocol Specific Drug: carboplatin Drug: irinotecan hydrochloride Phase 1

Detailed Description:


  • Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors.
  • Determine the safety profile and dose-limiting toxic effects of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine the preliminary anti-tumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of carboplatin and irinotecan.

Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for at least 30 days.

PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 6-9 months.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
Study Start Date : June 2001
Primary Completion Date : December 2003
Study Completion Date : December 2003

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U.S. FDA Resources

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


  • Histologically or cytologically confirmed solid tumor, including primary brain tumor

    • Progressive disease on standard therapy or for which no standard therapy exists
  • No symptomatic brain metastases



  • 1 to 21

Performance status:

  • Lansky 50-100% (age 10 and under)
  • Karnofsky 50-100% (over age 10)

Life expectancy:

  • At least 8 weeks


  • Absolute neutrophil count greater than 1,000/mm3
  • Platelet count greater than 100,000/mm3


  • Bilirubin no greater than 1.5 mg/dL
  • ALT no greater than 2.5 times upper limit of normal


  • Glomerular filtration rate at least 30 mL/min


  • No active infection
  • No serious uncontrolled medical disorder
  • No psychiatric disorder or other disorder that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 6 months since prior allogeneic bone marrow transplantation without evidence of acute or chronic graft versus host disease
  • At least 3 months since prior autologous bone marrow or peripheral blood stem cell transplantation
  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent immunotherapy


  • No more than 3 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent hormone replacement therapy or oral contraceptives allowed
  • No other concurrent hormonal therapy


  • At least 4 weeks since prior radiotherapy (including for brain metastases) and recovered
  • No concurrent radiotherapy


  • Not specified


  • No other concurrent investigational anticancer drugs
  • No other concurrent antitumor therapy
  • No concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (Neurontin)

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): NCT00024284

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2916
United States, Missouri
Washington University Medical Center
Saint Louis, Missouri, United States, 63105
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Bristol-Myers Squibb
National Cancer Institute (NCI)
Study Chair: Ashwin Gollerkeri, MD Bristol-Myers Squibb Identifier: NCT00024284     History of Changes
Other Study ID Numbers: CDR0000068908
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

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