Gefitinib in Treating Children With Refractory Solid Tumors
Unspecified Childhood Solid Tumor, Protocol Specific
Other: pharmacological study
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study Of ZD1839 (Iressa TM), An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, In Children With Refractory Solid Tumors|
- Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by the Common Terminology Criteria (CTC) version 2.0 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- DLT defined as hematologic and non-hematologic toxicities toxicities attributable to drug administration occurring during or immediately subsequent to the first course as assessed by CTC version 2.0 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of gefitinib [ Time Frame: At baseline, at 1, 2, 4, 6, 8, 12, and 24 hours after administration, at days 21 and 28, and at day 28 of subsequent courses ] [ Designated as safety issue: No ]
- Antitumor activity of gefitinib according to Response Evaluation Criteria in Solid Tumor (RECIST) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2002|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
Experimental: Treatment (gefitinib)
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Other Names:Other: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
I. Determine the maximum tolerated dose of gefitinib in children with refractory solid tumors.
II. Determine the dose-limiting toxicity of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine, preliminarily, the antitumor activity of this drug in these patients.
V. Correlate the pharmacogenetic polymorphisms of this drug with pharmacokinetics and pharmacodynamics in these patients.
OUTLINE: This is a dose-escalation, multicenter study. If myelosuppression is found to be the dose-limiting toxicity, patients are stratified according to prior therapy (more than 2 multiagent chemotherapy regimens or radiotherapy to more than 20% of the bone marrow or stem cell transplantation with or without total body irradiation vs more than 2 single-agent phase I or phase II agents) and extent of disease (bone marrow involvement vs meeting none of the stratum I criteria).
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gefitinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 3-45 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040781
|United States, California|
|Children's Oncology Group|
|Arcadia, California, United States, 91006-3776|
|Principal Investigator:||Najat Daw||Children's Oncology Group|