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Completed

NCT Number: NCT00110357

Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors

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.

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Key information

Conditions

Cancer Neoplasms Refractory Solid Tumor

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix Children'S Hospital, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cetuximab + Irinotecan

Drug

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.

Primary outcomes

  1. Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPIID) of Cetuximab in Combination With Irinotecan

    Time frame: Continuous assessment of safety throughout the entire study period and determination of doe-limiting toxicities during and at the end of Cycle 1.

    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)

Secondary outcomes

  1. Number of Participants With a Dose-Limiting Toxicity

    Time frame: Prior to each 21-day cycle until dose-limiting toxicities

    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).

  2. Maximum Plasma Concentration (Cmax)

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

    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.

  3. Area Under the Curve, Extrapolated to Infinity (AUC[INF])

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

    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.

  4. Terminal Half-Life (T-Half)

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

    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.

  5. Clearance Corrected for Body Surface Area (CL/BSA)

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

    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.

  6. Volume of Distribution at Steady State Corrected for Body Surface Area (VSS/BSA)

    Time frame: up to 168 hours after the start of the cetuximab infusion during the first 21-day cycle of the study

    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.

  7. Tumor Response

    Time frame: Every other 21-day cycle

    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.

  8. Human Anti-cetuximab Antibody (HACA) Response

    Time frame: Blood was drawn immediately prior to cetuximab infusions, on a 21-day cycle

    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.

  9. Number of Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs)

    Time frame: Weekly throughout the study and every 4 weeks thereafter

    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.

  10. Grade 3-4 Laboratory Abnormalities - Leukopenia

    Time frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment

    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

  11. Grade 3-4 Laboratory Abnormalities - Neutropenia

    Time frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment

    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

  12. Grade 3-4 Laboratory Abnormalities - Thrombocytopenia

    Time frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment

    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

  13. Grade 3/4 Laboratory Abnormalities - Hypomagnesemia

    Time frame: pretreatment visit, prior to each treatment cycle, weekly, and at the end of treatment

    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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 9, 2005
Registry last updated
Dec 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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