Clinical trials with intraperitoneal cisplatin microspheres for malignant ascites--a pilot study.
A new formulation (CDDP-MS), which is composed of lactic acid oligomer microspheres incorporating cisplatin, has been developed in a dosage form for peritoneal carcinomatosis. In this pilot study, CDDP-MS was used clinically for the treatment of malignant ascites induced by cancers of the digestive organs. Thirteen patients with malignant ascites received an i.p. administration of CDDP-MS, of which 12 received 100 mg and one received 200 mg of cisplatin/person to control the ascites. Total platinum levels in ascites and blood plasma were measured periodically. Intraperitoneal CDDP-MS decreased malignant ascites completely in eight patients and partially in four patients, and thus gave a response rate of 92%. The platinum concentration in ascites was maintained at a high level for a week after administration, whereas the concentrations in blood plasma were low. The side effects were well tolerated. Intraperitoneal CDDP-MS exhibits a marked therapeutic benefit with small systemic side effects for the treatment of malignant ascites.
Hagiwara
A
A
First Department of Surgery, Kyoto Prefectural University of Medicine, Japan.
Takahashi
T
T
Sawai
K
K
Sakakura
C
C
Tsujimoto
H
H
Osaki
K
K
Sakakibara
T
T
Ohyama
T
T
Ohgaki
M
M
Muranishi
S
S
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000503:physiopathology; D000368:Aged; D001201:Ascites / Q000188:drug therapy* / Q000209:etiology; D018279:Carcinoma, Signet Ring Cell / Q000188:drug therapy* / Q000503:physiopathology; D002945:Cisplatin / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D003110:Colonic Neoplasms / Q000188:drug therapy / Q000503:physiopathology; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007274:Injections, Intraperitoneal; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy / Q000503:physiopathology; D010865:Pilot Projects; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000503:physiopathology
D002945:Cisplatin