Cancer Clinical Trial
Official title:
Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
Verified date | November 2015 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 18 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Children'S Healthcare Of Atlanta | Atlanta | Georgia |
United States | Sidney Kimmel Cancer Center At Johns Hopkins | Baltimore | Maryland |
United States | The Children'S Hospital | Denver | Colorado |
United States | University Of Florida | Gainesville | Florida |
United States | University Of Texas Md Anderson Cancer Ctr | Houston | Texas |
United States | Vanderbilt University Medical Center Infectious Diseases | Nashville | Tennessee |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Phoenix Children'S Hospital | Phoenix | Arizona |
United States | University Of Arizona Health Sciences Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company | ImClone LLC |
United States,
Trippett 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan | MTD of cetuximab intravenous (IV) weekly + irinotecan IV x5 days x2 weeks (in a 3-week cycle) and RPIID of cetuximab IV weekly, as measured by dose-limiting toxicities (see outcome measure 2) | Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1. | No |
Secondary | Number of Participants With a Dose-Limiting Toxicity | Dose-limiting toxicities (DLTs)=serious drug side effects preventing further dose escalation. If 1 of the first 3 subjects developed a DLT during cycle 1 up to 3 additional subjects were enrolled at that dose level. The maximum dose level at which DLTs occurred in fewer than 2 out of 3 to 6 subjects was defined as the Maximum Tolerated Dose (MTD). | Prior to each 21-day cycle until dose-limiting toxicities | Yes |
Secondary | Maximum Plasma Concentration (Cmax) | The single dose pharmacokinetics (PK) of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; Cmax was evaluated based on concentration-time profile. | up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study | No |
Secondary | Area Under the Curve, Extrapolated to Infinity (AUC[INF]) | The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; AUC(INF) was evaluated based on concentration-time profile. | up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study | No |
Secondary | Terminal Half-Life (T-Half) | The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; T-half was evaluated based on concentration-time profile. | up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study | No |
Secondary | Clearance Corrected for Body Surface Area (CL/BSA) | The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; CL/BSA was evaluated based on concentration-time profile. | up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study | No |
Secondary | Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA) | The single dose PK of cetuximab was administered with an intravenous dose of irinotecan 16 to 20 mg/m2; VSS/BSA was evaluated based on concentration-time profile. | up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study | No |
Secondary | Tumor Response | Non-central nervous system (CNS) tumors evaluated using Response Evaluation Criteria In Solid Tumors (RECIST), criteria to define when cancer patients improve ("respond"), stay the same ("stable"), or worsen ("progression"). CNS tumors evaluated based on measurements by investigator, dependence on corticosteroids, and neurologic exam. | Every other 21-day cycle | No |
Secondary | Human Anti-cetuximab Antibody (HACA) Response | In order to be considered positive for anti-cetuximab a sample had to: 1) be evaluable (i.e., have a pre and at least one post-treatment timepoint), 2) have an anti-cetuximab value > 7 ng/mL and 3) have a post-treatment sample at least twice the pre-treatment level. | Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle | Yes |
Secondary | Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) | Toxicity assessments performed at least weekly from the 1st dose of study drug until at least 30 days after the final dose of study drug and thereafter every 4 weeks until all study-related toxicities resolved, returned to baseline, or were deemed irreversible, whichever was longer. Grade 3=severe AE; grade 4=disabling or life threatening. | Weekly throughout the study and every 4 weeks thereafter | Yes |
Secondary | Grade 3-4 Laboratory Abnormalities - Leukopenia | Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE | pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment | Yes |
Secondary | Grade 3-4 Laboratory Abnormalities - Neutropenia | Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe and undesirable AE; Grade 4=Life-threatening or disabling AE | pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment | Yes |
Secondary | Grade 3-4 Laboratory Abnormalities - Thrombocytopenia | Blood samples collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE | pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment | Yes |
Secondary | Grade 3/4 Laboratory Abnormalities - Hypomagnesemia | Blood samples were collected at selected times (pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment) for clinical laboratory evaluations. Grade 3= Severe AE; Grade 4=Life-threatening or disabling AE | pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|