Overview

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

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborators:
AstraZeneca
National Institutes of Health (NIH)
Treatments:
Camptothecin
Cefixime
Cefpodoxime
Cefpodoxime proxetil
Gefitinib
Irinotecan
Vincristine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.