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A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors


Phase 1
1 Year
21 Years
Not Enrolling
Both
Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ashwin Gollerkeri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Federal Government

Study ID:

CDR0000068908

NCT ID:

NCT00024284

Start Date:

June 2001

Completion Date:

December 2003

Related Keywords:

  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Washington University Medical CenterSaint Louis, Missouri  63105
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794