A Multi-Center Phase Ib Study of Oxaliplatin (NSC #266046) in Combination With Fluorouracil and Leucovorin in Pediatric Patients With Advanced Solid Tumors
I. Determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of
oxaliplatin when given together with fluorouracil and leucovorin calcium in pediatric
patients with recurrent or refractory solid tumors, including tumors of the CNS.
I. Determine the pharmacokinetic properties of oxaliplatin in this pediatric patient
II. Correlate alterations in accumulation of fludeoxyglucose F 18 with tumor response in
those patients who can readily undergo a positron emission tomography (PET) or PET/CT scan.
III. Assess the safety profile of this regimen in these patients. IV. Evaluate any
preliminary evidence of anti-tumor activity of this regimen in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study of oxaliplatin. Patients
are stratified according to solid tumor type (non-CNS vs CNS).
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1
followed by fluorouracil IV continuously over 46 hours on days 1-2. Courses repeat every 14
days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD based on the incidence of DLT as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 3.0
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
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