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[A phase I study of postoperative combination therapy with TS-1 and low dose cisplatin against stage IV gastric carcinoma].
- Source :
-
Gan to kagaku ryoho. Cancer & chemotherapy [Gan To Kagaku Ryoho] 2007 Apr; Vol. 34 (4), pp. 563-7. - Publication Year :
- 2007
-
Abstract
- A dose-escalation study was conducted for postoperative patients with stage IV gastric cancer to determine the recommended dose of daily intravenous cisplatin combined with a fixed dose of TS-1. TS-1 was administered orally twice daily for 2 weeks followed by a 1-week rest. The dose of TS-1 was based on the body surface area (BSA) as follows: 80 mg/day for BSA less than 1.25, 100 mg/day for BSA 1.25 to less than 1.50, and 120 mg/day for BSA 1.5 or more. Three dose levels of cisplatin (2, 4, 6 mg/m(2)) were studied, and two courses were performed. Cisplatin was infused on day 1-5 and 8-12 for 30 minutes. The National Cancer Institute common toxicity criteria (NCI-CTC Version 3) were used to evaluate the grade of toxicity. Three patients enrolled in each level. Dose escalation was performed when dose-limiting toxicities (DLT) were seen in 0/3, and 3 more cases of the same level were added when DLTs were seen 1-2/3. Maximum-tolerated dose (MTD) were determined when DLTs were seen in 3 cases. DLTs were not recorded during the administration of CDDP up to 4 mg/m(2). However, DLTs were seen 3/3 at level 3. From these results, cisplatin of 4 mg/m(2)was determined to be the recommended dose (RD) in this protocol for postoperative stage IV gastric carcinoma.
- Subjects :
- Administration, Oral
Aged
Cisplatin administration & dosage
Cisplatin blood
Drug Administration Schedule
Drug Combinations
Female
Gastrectomy
Humans
Male
Maximum Tolerated Dose
Middle Aged
Neoplasm Staging
Oxonic Acid administration & dosage
Oxonic Acid blood
Postoperative Period
Stomach Neoplasms pathology
Stomach Neoplasms surgery
Tegafur administration & dosage
Tegafur blood
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Stomach Neoplasms drug therapy
Subjects
Details
- Language :
- Japanese
- ISSN :
- 0385-0684
- Volume :
- 34
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Gan to kagaku ryoho. Cancer & chemotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 17431342