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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT00110357
Phase
PHASE1
Status
Completed

Conditions

  • Cancer
  • Refractory Solid Tumor

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Cetuximab + Irinotecan — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2005
Status verified
Nov 2015
Primary completion
Mar 31, 2008
Completion
Mar 31, 2008

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Group A
    1-12 years old
  • Active Comparator: Group B
    13-18 years old

Primary Outcome Measure

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. ]

Locations (9)

FacilityCityStateZIPSite coordinators
Phoenix Children'S HospitalPhoenixArizona85016-
University Of Arizona Health Sciences CenterTucsonArizona85724-
The Children'S HospitalDenverColorado80218-
University Of FloridaGainesvilleFlorida32610-
Children'S Healthcare Of AtlantaAtlantaGeorgia30322-
Sidney Kimmel Cancer Center At Johns HopkinsBaltimoreMaryland21231-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Vanderbilt University Medical Center Infectious DiseasesNashvilleTennessee37232-
University Of Texas Md Anderson Cancer CtrHoustonTexas77030-

Find similar trials in Phoenix, AZ

By research site
Phoenix Children'S Hospital· Phoenix, AZUniversity Of Arizona Health Sciences Center· Tucson, AZThe Children'S Hospital· Denver, COUniversity Of Florida· Gainesville, FLChildren'S Healthcare Of Atlanta· Atlanta, GASidney Kimmel Cancer Center At Johns Hopkins· Baltimore, MD

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