Phase I-II study of biweekly paclitaxel administration with fixed-dose-rate cisplatin in advanced gastric cancer

• Published in: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association Vol. 9; no. 1; pp. 36 - 43
• Main Authors: Yamaguchi, Kensei, Shimamura, Tomotaka, Komatsu, Yoshito, Takagane, Akinori, Yoshioka, Takashi, Saitoh, Soh, Munakata, Masaki, Sakata, Yu, Sato, Tsukasa, Arai, Tatsuhiro, Saitoh, Hiroshi
• Format: Journal Article
• Language: English
• Published: Japan Springer Nature B.V 01.02.2006
• Subjects: Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cisplatin - administration & dosage; Dose-Response Relationship, Drug; Female; Gastric cancer; Humans; Intestinal Neoplasms - drug therapy; Intestinal Neoplasms - surgery; Male; Maximum Tolerated Dose; Middle Aged; Neoplasm Staging; Oncology; Paclitaxel - administration & dosage; Stomach Neoplasms - drug therapy; Stomach Neoplasms - surgery; Survival Rate
• ISSN: 1436-3291; 1436-3305
• DOI: 10.1007/s10120-005-0355-2

Both paclitaxel (TXL) and cisplatin (CDDP) show efficacy against gastric cancer. The aim of this phase I-II study was to determine the maximum tolerated dose (MTD) and to evaluate the toxicity and efficacy of combination chemotherapy with these two agents. Nineteen patients entered the phase I part of the study, and 21 patients entered the phase II part. TXL infusions were administered on days 1 and 15, with a fixed 3mg/m2 dose of CDDP. In the phase I part of the study, we determined dose level 5, which represented a TXL dose of 18 mg/m2, with CDDP 3 mg/m2, to be the MTD. The recommended dose (RD) was level 4, with a TXL dose of 16 mg/m2 with CDDP, 3 mg/m2. In the phase II part of the study, the response rate was 25.0%; five patients had a partial response, seven had stable disease, 6 had progressive disease, and 2 were not evaluable. Grade 3 or 4 neutropenia was the most common adverse event and occurred in 65% of the patients. During treatment, 25% of the patients received granulocyte colony-stimulating factor, but febrile neutropenia was not shown in any of the patients. Major nonhematological toxicities were nausea/vomiting, anorexia, fatigue, alopecia, and sensory neuropathy. Adverse reactions of grade 3 or 4 were shown by two patients, one with anorexia (5%) and the other with sensory neuropathy (5%). The RD was determined to be TXL 14 mg/m2, with CDDP 3 mg/m2.