Expired Study
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Arcadia, California 91006


Phase I trial to study the effectiveness of gefitinib in treating children who have refractory solid tumors. Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth

Study summary:

PRIMARY OBJECTIVES: 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.


Inclusion Criteria: - Histologically confirmed solid tumor at original diagnosis - Refractory to conventional therapy and other therapies of higher priority according to the COG Phase I/II priority list or no conventional therapy exists - No primary CNS tumors or known metastases to the CNS - Performance status - Karnofsky 50-100% (over 10 years of age) - Performance status - Lansky 50-100% (10 years of age and under) - At least 8 weeks - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 50,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 3 times ULN - Albumin at least 2 g/dL - Creatinine normal for age - Glomerular filtration rate at least 70 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled infection - At least 6 months since prior allogeneic stem cell transplantation (SCT) - No evidence of active graft-versus-host disease - At least 1 week since prior biologic agents - At least 1 week since prior hematopoietic growth factors - Recovered from prior immunotherapy - At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered - No concurrent tamoxifen - At least 2 weeks since prior local palliative (small port) radiotherapy - At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or more of the pelvis (6 weeks for radiotherapy to other substantial amount of bone marrow) - Recovered from prior radiotherapy - No concurrent drugs with known corneal toxicity (e.g., chlorpromazine, Amiodarone, or chloroquine) - No concurrent enzyme-activating anticonvulsants - No concurrent proton pump inhibitors or H-2 blockers within 4 hours of gefitinib administration

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Gefitinib in Treating Children With Refractory Solid Tumors

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

Overall Status:


Study Phase:

Phase 1



Minimum Age:


Maximum Age:

21 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Endpoint Classification: Pharmacokinetics Study,

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Najat Daw
Principal Investigator
Children's Oncology Group

Study Dates

Start Date:June 2002
Primary Completion Date:October 2004
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 22, 2013
First Received Date:July 8, 2002

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Antitumor activity of gefitinib according to Response Evaluation Criteria in Solid Tumor (RECIST)
Time Frame:Up to 2 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Description:Given orally
Arm Name:Treatment (gefitinib)
Other Name:Iressa
Intervention Type:Other
Name:pharmacological study
Description:Correlative studies
Arm Name:Treatment (gefitinib)
Other Name:pharmacological studies
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Treatment (gefitinib)

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (gefitinib)
Description:Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Jimeno A, Daw NC, Amador ML, Cusatis G, Kulesza P, Krailo M, Ingle AM, Blaney SM, Adamson P, Hidalgo M. Analysis of biologic surrogate markers from a Children's Oncology Group Phase I trial of gefitinib in pediatric patients with solid tumors. Pediatr Blood Cancer. 2006 Jan 19; [Epub ahead of print]
Reference Type:Results Reference
Citation:Daw NC, Furman WL, Stewart CF, Iacono LC, Krailo M, Bernstein ML, Dancey JE, Speights RA, Blaney SM, Croop JM, Reaman GH, Adamson PC; Children's Oncology Group. Phase I and pharmacokinetic study of gefitinib in children with refractory solid tumors: a Children's Oncology Group Study. J Clin Oncol. 2005 Sep 1;23(25):6172-80.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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