Phase I study of combination chemotherapy with irinotecan hydrochloride and nedaplatin for cervical squamous cell carcinoma: Japanese Gynecologic Oncology Group study

被引:25
作者
Yamamoto, Kaichtro [1 ]
Kokawa, Katsuji
Umesaki, Naohiko [2 ]
Nishimura, Ryuichiro [3 ]
Hasegawa, Kazuo [4 ]
Konishi, Ikuo [5 ]
Saji, Fumitaka [6 ]
Nishida, Masato [7 ]
Noguchi, Hiroshi [8 ]
Takizawa, Ken [9 ]
机构
[1] Kinki Univ, Sch Med, Dept Obstet & Gynecol, Sakai Hosp,Minami Ku, Osaka 5900132, Japan
[2] Wakayama Med Univ, Dept Obstet & Gynecol, Wakayama 6410012, Japan
[3] Hyogo Canc Ctr, Dept Gynecol Oncol, Akashi, Hyogo 6738558, Japan
[4] Inamino Hosp, Kakogawa, Hyogo 6750104, Japan
[5] Kyoto Univ, Dept Gynecol & Obstet, Grad Sch Med, Sakyo Ku, Kyoto 6068507, Japan
[6] Natl Hosp Org, Kure Med Ctr, Hiroshima 7370023, Japan
[7] Natl Hosp Org, Kasumigaura Med Ctr, Tsuchiura, Ibaraki 3008585, Japan
[8] Natl Hosp Org, Matsumoto Med Ctr, Nagano 3998701, Japan
[9] Japanese Fdn Canc Res, Dept Gynecol, Canc Inst Hosp, Koto Ku, Tokyo 1358550, Japan
关键词
irinotecan hydrochloride; nedaplatin; phase I study; cervical cancer; squamous cell carcinoma; COLONY-STIMULATING FACTOR; RANDOMIZED-TRIAL; 1ST-LINE CHEMOTHERAPY; CANCER; CISPLATIN; THERAPY; LINES;
D O I
10.3892/or_00000316
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
The aim of this study (JGOG 1063) was to determine the recommended dose (RD) for combination chemotherapy with irinotecan hydrochloride (CPT-11) and nedaplatin (NDP) for advanced cervical squamous cell carcinoma. CPT-11 was given intravenously in fixed doses of 60 mg/m(2) on days I and 8 and NDP, in escalating doses, on day 1, every 4 weeks. A total of 15 patients were enrolled in the study. At level I (NDP: 50 mg/m(2)), one of the 3 patients developed grade 3 diarrhea, so 3 additional patients were enrolled at this level. As none of the 3 additional patients exhibited dose-limiting toxicity, level I was elevated to level 2 (NDP: 60 mg/m(2)). The maximum tolerated dose was not reached, even at the highest dose level (level 4; NDP: 80 mg/m(2)). No further dose escalation was carried out, and level 4 (CPT-11: 60 mg/m(2), NDP: 80 mg/m(2)) was determined as the RD.
引用
收藏
页码:1005 / 1009
页数:5
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