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Gefitinib in Treating Children With Refractory Solid Tumors
This study has been completed.
First Received: July 8, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00040781
  Purpose

RATIONALE: Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase I trial to study the effectiveness of gefitinib in treating children who have refractory solid tumors.


Condition Intervention Phase
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: gefitinib
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study Of ZD1839 (Iressa), An Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, In Children With Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of gefitinib in children with refractory solid tumors.
  • Determine the dose-limiting toxicity of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine, preliminarily, the antitumor activity of this drug in these patients.
  • 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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Under 22

Performance status:

  • Karnofsky 50-100% (over 10 years of age) OR
  • Lansky 50-100% (10 years of age and under)

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • 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)

Hepatic:

  • 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

Renal:

  • Creatinine normal for age OR
  • Glomerular filtration rate at least 70 mL/min

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • 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

Chemotherapy:

  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered

Endocrine therapy:

  • No concurrent tamoxifen

Radiotherapy:

  • 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

Surgery:

  • Not specified

Other:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040781

  Show 23 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Najat C. Daw, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069406, COG-ADVL0016, NCI-03-C-0062
Study First Received: July 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00040781     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Gefitinib
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009