Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00024284
First received: September 13, 2001
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: carboplatin
Drug: irinotecan hydrochloride
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: June 2001
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 1 to 21

Performance status:

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

Life expectancy:

  • At least 8 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

  • Glomerular filtration rate at least 30 mL/min

Other:

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • Not specified

Other:

  • No other concurrent investigational anticancer drugs
  • No other concurrent antitumor therapy
  • No concurrent anticonvulsants (e.g., phenytoin, phenobarbital, or carbamazepine) except gabapentin (Neurontin)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024284

Locations
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
Investigators
Study Chair: Ashwin Gollerkeri, MD Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00024284     History of Changes
Other Study ID Numbers: CDR0000068908, BMS-CA124-001, CNMC-2782, MSKCC-01071, SJCRH-CARCPT, NCI-G01-2016
Study First Received: September 13, 2001
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neoplasms
Carboplatin
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014