PMID- 17393073 OWN - NLM STAT- MEDLINE DCOM- 20071105 LR - 20181113 IS - 0167-6997 (Print) IS - 0167-6997 (Linking) VI - 25 IP - 5 DP - 2007 Oct TI - Phase II study of Triapine in patients with metastatic renal cell carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC IND.161). PG - 471-7 AB - Triapine is a novel small molecule ribonucleotide reductase inhibitor that showed activity in renal cell carcinoma (RCC) cell lines. Evaluating new agents with novel mechanisms remains of interest for patients with incurable RCC. This was a single-arm, multicentre phase II trial where Triapine was given at a schedule of 96 mg/m2 2-h infusion daily x 4 repeated every 2 weeks in patients with recurrent RCC. A median of four cycles of Triapine was administered to 19 eligible patients. One response was seen (7%.) Median time to progression was 3.6 months. Common adverse events (AEs) were grade 1-2, with fatigue in 74%, nausea in 68% and vomiting in 58%. However grade 3/4 neutropenia was seen in 79% and acute reactions of hypoxia, hypotension, methemoglobinemia were seen. Dose reductions/delays due to AEs were common with only 47% of patients receiving > 90% of planned dose intensity. The study closed, at the end of stage 1 as it did not meet the minimal efficacy criteria to proceed. Further evaluation of Triapine at this dose and schedule in patients with advanced kidney cancer is not recommended. FAU - Knox, Jennifer J AU - Knox JJ AD - Department of Medical Oncology, University Health Network-OCI/Princess Margaret Hospital, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. jennifer.knox@uhn.on.ca FAU - Hotte, Sebastien J AU - Hotte SJ FAU - Kollmannsberger, Christian AU - Kollmannsberger C FAU - Winquist, Eric AU - Winquist E FAU - Fisher, Bryn AU - Fisher B FAU - Eisenhauer, Elizabeth A AU - Eisenhauer EA LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20070328 PL - United States TA - Invest New Drugs JT - Investigational new drugs JID - 8309330 RN - 0 (Antineoplastic Agents) RN - 0 (Pyridines) RN - 0 (Thiosemicarbazones) RN - 143621-35-6 (3-aminopyridine-2-carboxaldehyde thiosemicarbazone) RN - EC 1.17.4.- (Ribonucleotide Reductases) SB - IM MH - Aged MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - Canada MH - Carcinoma, Renal Cell/*drug therapy MH - Clinical Trials as Topic MH - Female MH - Humans MH - Kidney Neoplasms/*drug therapy MH - Male MH - Middle Aged MH - Pyridines/adverse effects/*therapeutic use MH - Ribonucleotide Reductases/antagonists & inhibitors MH - Thiosemicarbazones/adverse effects/*therapeutic use MH - Treatment Outcome EDAT- 2007/03/30 09:00 MHDA- 2007/11/06 09:00 CRDT- 2007/03/30 09:00 PHST- 2007/01/12 00:00 [received] PHST- 2007/02/20 00:00 [accepted] PHST- 2007/03/30 09:00 [pubmed] PHST- 2007/11/06 09:00 [medline] PHST- 2007/03/30 09:00 [entrez] AID - 10.1007/s10637-007-9044-9 [doi] PST - ppublish SO - Invest New Drugs. 2007 Oct;25(5):471-7. doi: 10.1007/s10637-007-9044-9. Epub 2007 Mar 28.