At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed diagnosis of a solid tumor that has progressed on or after standard therapy, or for which no standard effective therapy is known
- ✓Children age 1–18 years
- ✕Presence of active infection
- ✕Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study
- ✕Inadequate bone marrow, hepatic, or renal function
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Cetuximab + Irinotecan for Cancer and Refractory Solid Tumor. Completed, enrolled 48 participants across 9 sites.
Detailed Summary
The purpose of this clinical research study is to establish the maximum tolerated dose and recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and adolescent patients with refractory solid tumors.
Study Details
Timeline
Interventions
Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 16 or 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.
Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.