ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT00132158
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. In this study the intravenous (given into the vein) formula of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12. Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.

Key Dates

Start date
Sep 30, 2005
Status verified
Apr 2012
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: 1

Primary Outcome Measure

To estimate the maximum tolerated dose (MTD) of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefitinib. [ Time Frame: Within the first 30 days of completion of first cycle of chemotherapy. ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105-

Find similar trials in Memphis, TN

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By specialty
OncologyNeuro-oncologyPediatric oncology
By research site
St. Jude Children's Research Hospital· Memphis, TN

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