- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00040781
Gefitinib in Treating Children With Refractory Solid Tumors
A Phase I Study Of ZD1839 (Iressa TM), An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, In Children With Refractory Solid Tumors
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
California
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Arcadia, California, Forenede Stater, 91006-3776
- Children's Oncology Group
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
|
Korrelative undersøgelser
Gives oralt
Andre navne:
Korrelative undersøgelser
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by the Common Terminology Criteria (CTC) version 2.0
Tidsramme: 28 days
|
28 days
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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
Tidsramme: 28 days
|
28 days
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Pharmacokinetics of gefitinib
Tidsramme: 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
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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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Antitumor activity of gefitinib according to Response Evaluation Criteria in Solid Tumor (RECIST)
Tidsramme: Up to 2 years
|
Up to 2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Najat Daw, Children's Oncology Group
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCI-2012-01874
- U01CA097452 (U.S. NIH-bevilling/kontrakt)
- ADVL0016
- CDR0000069406 (Registry Identifier: PDQ (Physician Data Query))
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