PMID- 9157074 OWN - NLM STAT- MEDLINE DCOM- 19970520 LR - 20191024 IS - 0167-6997 (Print) IS - 0167-6997 (Linking) VI - 14 IP - 4 DP - 1996 TI - Phase I trial of recombinant platelet factor 4 (rPF4) in patients with advanced colorectal carcinoma. PG - 387-9 AB - BACKGROUND: Recombinant platelet factor 4 (rPF4) is a naturally occurring protein found in platelet alpha granules that can inhibit angiogenesis. METHODS: In this Phase I trial, 9 patients with metastatic colorectal cancer who had failed 5-FU treatment received rPF4 at doses ranging from 0.3 to 3.0 mg/kg via 30-minute infusion. Three additional patients were treated with the 3 mg/kg dose over a 6-hour period of infusion. RESULTS: The only toxicity encountered was mild leg twitching in 2/3 patients treated with the 6-hour infusion. One patient with a history of phlebitis developed a lower extremity deep venous thrombosis after the first dose of rPF4. A mild rise in fibrinogen level was noted in several patients. Of the 11 evaluable patients, there were no clinical responses to treatment. CONCLUSIONS: rPF4 is well tolerated at the doses and schedules tested. No clinical responses were observed. Prolonged infusion schedules should be investigated. FAU - Belman, N AU - Belman N AD - Department of Medicine, M.S. Hershey Medical Center, Pennsylvania State University, Hershey 17033, USA. FAU - Bonnem, E M AU - Bonnem EM FAU - Harvey, H A AU - Harvey HA FAU - Lipton, A AU - Lipton A LA - eng PT - Clinical Trial PT - Clinical Trial, Phase I PT - Journal Article PL - United States TA - Invest New Drugs JT - Investigational new drugs JID - 8309330 RN - 0 (Coagulants) RN - 37270-94-3 (Platelet Factor 4) SB - IM MH - Adult MH - Aged MH - Coagulants/*administration & dosage/therapeutic use MH - Colorectal Neoplasms/*drug therapy MH - Female MH - Humans MH - Infusions, Intravenous MH - Male MH - Middle Aged MH - Platelet Factor 4/*adverse effects/therapeutic use EDAT- 1996/01/01 00:00 MHDA- 1996/01/01 00:01 CRDT- 1996/01/01 00:00 PHST- 1996/01/01 00:00 [pubmed] PHST- 1996/01/01 00:01 [medline] PHST- 1996/01/01 00:00 [entrez] AID - 10.1007/BF00180815 [doi] PST - ppublish SO - Invest New Drugs. 1996;14(4):387-9. doi: 10.1007/BF00180815.