Phase I trial of recombinant platelet factor 4 (rPF4) in patients with advanced colorectal carcinoma.
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.
Belman
N
N
Department of Medicine, M.S. Hershey Medical Center, Pennsylvania State University, Hershey 17033, USA.
Bonnem
E M
EM
Harvey
H A
HA
Lipton
A
A
D000328:Adult; D000368:Aged; D003029:Coagulants / Q000008:administration & dosage* / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010978:Platelet Factor 4 / Q000009:adverse effects* / Q000627:therapeutic use
D003029:Coagulants; D010978:Platelet Factor 4