Solid Tumors Clinical Trial
Official title:
A Phase I Study of ZD1839 (Iressa) in Combination With Irinotecan (Camptosar or CPT-11) and Vincristine in Pediatric Patients With Refractory Solid Tumors
Verified date | October 2011 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital | AstraZeneca, National Institutes of Health (NIH) |
United States,
A Phase I Study of Gefitinib and irinotecan (IRN) in pediatric patients with refractory solid tumors. WL Furman et al. Vol 22, No 14S (July 15 Supplement), 2004: 8521
Effect of Gefitinib on the bioavailability of oral irinotecan in children with refractory solid tumors. K.R. Crews, W.L. Furman, J.C. Panetta, B.B. Freeman, L.C. Iacono, P.J. Houghton, C.F. Stewart. Proceeding of ASCO. Vol 22, No 14S, 2004:2012.
Effect of gefitinib on the systemic dispositon of intravenous irinotecan (IRN) in pediatric patients with refractory solid tumors. L.C. Iacono, W.L. Furman, K.R. Crews, J.C. Panetta, B.B. Freeman, N.C. Daw, C.F. Stewart. Proceedings of ASCO. Vol 22, No 14
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