Gefitinib in Treating Children With Refractory Solid Tumors

NCT00040781 | Completed Phase 1

• 4 other identifiers: NCI-2012-01874ADVL0016U01CA097452CDR0000069406
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (3)

• Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by the Common Terminology Criteria (CTC) version 2.0

  28 days

• 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

  28 days

• Pharmacokinetics of gefitinib

  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

Secondary Outcomes (1)

• Antitumor activity of gefitinib according to Response Evaluation Criteria in Solid Tumor (RECIST)

  Up to 2 years

Study Arms (1)

Treatment (gefitinib)

EXPERIMENTAL

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Drug: gefitinib; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

gefitinib DRUG

Given orally

Also known as: Iressa, ZD 1839

Treatment (gefitinib)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (gefitinib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (gefitinib)

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Najat Daw

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Primary Completion: October 1, 2004
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)