A multi-center phase Ib study of oxaliplatin (NSC#266046) in combination with fluorouracil and leucovorin in pediatric patients with advanced solid tumors Journal Article
| Authors: | Macy, M. E.; Duncan, T.; Whitlock, J.; Hunger, S. P.; Boklan, J.; Narendren, A.; Herzog, C.; Arceci, R. J.; Bagatell, R.; Trippett, T.; Christians, U.; Rolla, K.; Ivy, S. P.; Gore, L. |
| Article Title: | A multi-center phase Ib study of oxaliplatin (NSC#266046) in combination with fluorouracil and leucovorin in pediatric patients with advanced solid tumors |
| Abstract: | Background: Platinum agents have been used for a variety of cancers, including pivotal use in pediatric tumors for many years. Oxaliplatin, a third generation platinum, has a different side effect profile and may provide improved activity in pediatric cancers. Procedure: Patients 21 years or younger with progressive or refractory malignant solid tumors, including tumors of the central nervous system were enrolled on this multi-center open label, non-randomized Phase 1 dose escalation study. The study used a standard 3+3 dose escalation design with 2 dose levels (85 and 100mg/m2) with an expansion cohort of 15 additional patients at the recommended dose. Patients received oxaliplatin at the assigned dose level and 5-fluorouracil (5-FU) bolus 400mg/m2 followed by a 46-hour 5-FU infusion of 2,400mg/m2 every 14 days. The leucovorin dose was fixed at 400mg/m2 for all cohorts. Results: Thirty-one evaluable patients were enrolled, 8 at 85mg/m2 and 23 at 100mg/m2 for a total of 121 courses. The median age was 12 years (range 2-19 years). The main toxicities were hematologic, primarily neutrophils and platelets. The most common non-hematologic toxicities were gastrointestinal. Stable disease was noted in 11 patients (54% of evaluable patients) and 1 confirmed partial response in a patient with osteosarcoma. Conclusions: The maximum planned dose of oxaliplatin at 100mg/m2 per dose in combination with 5-FU and leucovorin was safe and well tolerated and in this patient population. This combination demonstrated modest activity in patients with refractory or relapsed solid tumor and warrants further study. © 2012 Wiley Periodicals, Inc. |
| Keywords: | chemotherapy; oxaliplatin; 5-fluorouracil; phase 1; pediatrics; folfox |
| Journal Title: | Pediatric Blood and Cancer |
| Volume: | 60 |
| Issue: | 2 |
| ISSN: | 1545-5009 |
| Publisher: | Wiley Periodicals, Inc |
| Date Published: | 2013-02-01 |
| Start Page: | 230 |
| End Page: | 236 |
| Language: | English |
| DOI: | 10.1002/pbc.24278 |
| PROVIDER: | scopus |
| PMCID: | PMC3522763 |
| PUBMED: | 23024067 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 2 January 2013" - "CODEN: PBCEA" - "Source: Scopus" |
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