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

• Published in: Oncology reports Vol. 21; no. 4; pp. 1005 - 1009
• Main Authors: YAMAMOTO, Kaichiro, KOKAWA, Katsuji, UMESAKI, Naohiko, NISHIMURA, Ryuichiro, HASEGAWA, Kazuo, KONISHI, Ikuo, SAJI, Fumitaka, NISHIDA, Masato, NOGUCHI, Hiroshi, TAKIZAWA, Ken
• Format: Journal Article
• Language: English
• Published: Athens Spandidos 01.04.2009
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Carcinoma, Squamous Cell - drug therapy; Female; Female genital diseases; Gynecology. Andrology. Obstetrics; Humans; Irinotecan; Medical sciences; Middle Aged; Organoplatinum Compounds - administration & dosage; Organoplatinum Compounds - adverse effects; Tumors; Uterine Cervical Neoplasms - drug therapy; Asia; Japan; Antineoplastic agent; Skin disease; Basal cell carcinoma; Isomerases; Cancerology; Uterine cervix squamous cell carcinoma; Hydrochlorides; phase I study; Topoisomerase I inhibitor; Platinum II Complexes; Camptothecin derivatives; Drug combination; Squamous cell carcinoma; Enzyme; DNA topoisomerase; Enzyme inhibitor; Malignant tumor; Female genital diseases; Irinotecan; Phase I trial; Nedaplatin; Combined treatment; irinotecan hydrochloride; Uterine cervix diseases; Cervical cancer; Cancer
• ISSN: 1021-335X; 1791-2431
• DOI: 10.3892/or_00000316

The aim of this study (JGOG1063) 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/m2 on days 1 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 1 (NDP: 50 mg/m2), 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 1 was elevated to level 2 (NDP: 60 mg/m2). The maximum tolerated dose was not reached, even at the highest dose level (level 4; NDP: 80 mg/m2). No further dose escalation was carried out, and level 4 (CPT-11: 60 mg/m2, NDP: 80 mg/m2) was determined as the RD.