Phase II clinical trial of SKI-2053R, a new platinum analog, in the treatment of patients with advanced gastric adenocarcinoma.
BACKGROUND
SKI-2053R (SK Chemicals, Kyungki-Do, South Korea) is a new platinum derivative with antitumor activity against various cell lines, including cisplatin-resistant tumor cell lines. Preclinical studies have suggested that it is less nephrotoxic than cisplatin. This study evaluated the efficacy and toxicity of SKI-2053R in the treatment of patients with advanced gastric adenocarcinoma.


METHODS
Thirty-seven patients with advanced gastric adenocarcinoma that was unresectable or metastatic were treated. No prior chemotherapy or radiotherapy was allowed. Patients received SKI-2053R 360 mg/m(2) by 1-hour infusion on Day 1. After the first cycle, subsequent doses were adjusted according to the toxicity. Courses were repeated every 28 days.


RESULTS
Thirty-five patients were evaluable for response and toxicity. Six patients achieved a major response (17%; 95% confidence interval, 8-33%); 2 were complete and 4 were partial responses. The median duration of response was 7.2 months, with a range of 1-20 months. Patients could tolerate the treatment without significant toxicity. No patients had Grade 3 or 4 toxicity. The most frequent toxicity was Grade 1 or 2 proteinuria (26% of cycles), but it was mild and transient. Leukopenia, thrombocytopenia, azotemia, nausea and vomiting, and neurotoxicity were not frequent. These low toxicity profiles indicated that the dose of SKI-2053R could be increased in future studies.


CONCLUSIONS
SKI-2053R was active in the treatment of patients with gastric adenocarcinoma and had favorable toxicity profiles.
Kim
N K
NK
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Im
S A
SA
Kim
D W
DW
Lee
M H
MH
Jung
C W
CW
Cho
E K
EK
Lee
J T
JT
Ahn
J S
JS
Heo
D S
DS
Bang
Y J
YJ
D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D005260:Female; D006801:Humans; D008297:Male; D008314:Malonates / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D013274:Stomach Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D008314:Malonates; D009944:Organoplatinum Compounds; C090717:SKI 2053R