Status:
COMPLETED
Study of ZD1839 Combined With Irinotecan and Vincristine in Pediatric Patients With Refractory Solid Tumors
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
AstraZeneca
National Institutes of Health (NIH)
Conditions:
Solid Tumors
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
Objectives of this study are: * To determine the dose-limiting toxicities (DLT) of the combination of irinotecan and ZD1839 when given on this schedule. * To characterize the pharmacokinetics and pha...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00186979
Start Date
May 1 2003
End Date
March 1 2010
Last Update
April 26 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105