Clinical trial · Interventional
Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
NCT00110357CI-TRIAL-00020319completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Refractory Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab + Irinotecan | Drug | Cetuximab/Irinotecan Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- 1-12 years old
- interventionNames
- Drug: Cetuximab + Irinotecan
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- 13-18 years old
- interventionNames
- Drug: Cetuximab + Irinotecan
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan
- timeFrame
- Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of a solid tumor which has progressed on, or following standard therapy, or for which no standard effective therapy is known. * Children age 1-18 years. Exclusion Criteria: * 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.
References
Publications (1)
- BACKGROUNDTrippett TM, Herzog C, Whitlock JA, Wolff J, Kuttesch J, Bagatell R, Hunger SP, Boklan J, Smith AA, Arceci RJ, Katzenstein HM, Harbison C, Zhou X, Lu H, Langer C, Weber M, Gore L. Phase I and pharmacokinetic study of cetuximab and irinotecan in children with refractory solid tumors: a study of the pediatric oncology experimental therapeutic investigators' consortium. J Clin Oncol. 2009 Oct 20;27(30):5102-8. doi: 10.1200/JCO.2008.20.8975. Epub 2009 Sep 21. PMID 19770383