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


Phase 1
1 Year
18 Years
Not Enrolling
Both
Cancer, Refractory Solid Tumor

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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)

Outcome 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.

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA225-085

NCT ID:

NCT00110357

Start Date:

August 2005

Completion Date:

March 2008

Related Keywords:

  • Cancer
  • Refractory Solid Tumor
  • Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
University of FloridaGainesville, Florida  32610-0277
University of Arizona Health Sciences CenterTucson, Arizona  85724
Children's Healthcare of AtlantaAtlanta, Georgia  30342
The Children'S HospitalDenver, Colorado  80218
Sidney Kimmel Cancer Center At Johns HopkinsBaltimore, Maryland  21231
Vanderbilt University Medical Center Infectious DiseasesNashville, Tennessee  37232
University Of Texas Md Anderson Cancer CtrHouston, Texas  77030