A Dose Finding Study (Phase I) of the Combination of ZD1839 (IressaÂ®) and Irinotecan (CamptosarTM) Given Orally in Children with Refractory Solid Tumors (AstraZeneca Protocol IRUSIRES0181)

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Research

Protocol

POCPZD: A Dose Finding Study (Phase I) of the Combination of ZD1839 (IressaÂ®) and Irinotecan (CamptosarTM) Given Orally in Children with Refractory Solid Tumors (AstraZeneca Protocol IRUSIRES0181)

Diseases

Solid Tumor : Refractory solid tumors including glioblastoma, rhabdomyosarcoma, neuroblastoma, and osteosarcoma

Description

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.

Objectives

To estimate the highest dose of irinotecan that can be given by mouth when given with a fixed dose of oral ZD1839
To learn the effects (good and bad) of these two anticancer drugs working together.
To find out how the body uses ZD1839 and irinotecan.

Eligibility

Patient’s age is less than or equal to 21 year at the time of study entry
Patient has histological or pathological confirmed diagnosis of a recurrent solid tumor that did not respond to standard treatment or one for which there is no known therapy
Patient has adequate performance status, along with adequate function of the liver, kidney and bone marrow
Patient is not receiving any other cytotoxic or investigational drug and does not have evidence of another active illness

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Lisa M. McGregor, MD, PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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