Phase I Study of Erbitux™ (Cetuximab) in Pediatric Patients With Refractory Solid Tumors
1 Year
18 Years
Both
Cancer, Refractory Solid Tumor
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 Center | New York, New York 10021 |
| Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
| University of Florida | Gainesville, Florida 32610-0277 |
| University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
| Children's Healthcare of Atlanta | Atlanta, Georgia 30342 |
| The Children'S Hospital | Denver, Colorado 80218 |
| Sidney Kimmel Cancer Center At Johns Hopkins | Baltimore, Maryland 21231 |
| Vanderbilt University Medical Center Infectious Diseases | Nashville, Tennessee 37232 |
| University Of Texas Md Anderson Cancer Ctr | Houston, Texas 77030 |
