Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
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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 |
| Study Start Date: | June 2001 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
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 |
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| 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 | |
| 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 Irinotecan Carboplatin Camptothecin 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 May 22, 2013