Study of ZD1839 Combined With Irinotecan and Vincristine in Pediatric Patients With Refractory Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

The purpose of this protocol is to estimate the maximum tolerated dose of gefitinib in combination with fixed dose of irinotecan and vincristine in patients with refractory solid tumors.

Key facts

Study ID

NCT00186979

Run by

St. Jude Children's Research Hospital

People needed

34

Starts

2003-05-01

Expected to finish

2010-03-01

Last updated by the study team

2017-04-26

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Younger than 22 years of age.
• Histologic verification of solid tumor malignancy at original diagnosis.
• Has disease considered refractory to conventional therapy or no conventional therapy exists.
• Adequate performance status, bone marrow, liver and kidney function.
• Patients must not have had any previous allergic reactions to penicillin or cephalosporins

You may not qualify if…

• Known severe hypersensitivity to ZD1839 or any of the excipients of this product
• Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort, and CYP3A4 inhibitors
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
• Incomplete healing from previous oncologic or other major surgery
• Pregnant or breast-feeding
• Patients who have an uncontrolled infection
• Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
• As judged by the investigator, any evidence of uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
• Evidence of any other significant clinical disorder or laboratory finding that makes is undesirable for the subject to participate in the trial.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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