Phase 1
Completed N=46
Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Cancer · Refractory Solid Tumor
Source: ClinicalTrials.gov NCT00110357 ↗
Enrolled (actual)
46
Serious AEs
52.2%
Results posted
Aug 2009
Primary outcomePrimary: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan — 250; 250; 16; 20 mg/m2
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan |
250; 250; 16; 20; 250; 250 | — |
| SECONDARY Number of Participants With a Dose-Limiting Toxicity |
1; 2; 0; 0; 1; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) |
50.5; 112.9; 163.7; 53.4; 83.1; 148.5 | — |
| SECONDARY Area Under the Curve, Extrapolated to Infinity (AUC[INF]) |
1598.3; 8871.2; 17706.0; 1925.2; 7027.3; 13410.4 | — |
| SECONDARY Terminal Half-Life (T-Half) |
31.0; 75.2; 110.3; 37.9; 61.1; 81.9 | — |
| SECONDARY Clearance Corrected for Body Surface Area (CL/BSA) |
0.057; 0.017; 0.015; 0.040; 0.021; 0.020 | — |
| SECONDARY Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA) |
2.081; 1.860; 2.157; 2.138; 1.887; 2.179 | — |
| SECONDARY Tumor Response |
2; 0; 10; 8; 10; 11 | — |
| SECONDARY Human Anti-cetuximab Antibody (HACA) Response |
27; 15; 1 | — |
| SECONDARY Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) |
0; 5; 2; 5; 3; 1 | — |
| SECONDARY Grade 3-4 Laboratory Abnormalities - Leukopenia |
3; 0; 3; 4; 2; 2 | — |
| SECONDARY Grade 3-4 Laboratory Abnormalities - Neutropenia |
3; 0; 3; 3; 3; 1 | — |
| SECONDARY Grade 3-4 Laboratory Abnormalities - Thrombocytopenia |
1; 0; 3; 2; 0; 0 | — |
| SECONDARY Grade 3/4 Laboratory Abnormalities - Hypomagnesemia |
1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00110357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.