Clinical trial NCT00024284: Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
Official title: A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Childhood Solid Tumor, Protocol Specific
Keywords: unspecified childhood solid tumor, protocol specific
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Ashwin Gollerkeri, MD
role: STUDY_CHAIR
References: