Phase I study of daily cisplatin and concurrent radiotherapy in patients with cervical carcinoma.

Abstract

OBJECTIVE:

Chemoradiation based on cisplatin is the standard treatment for locally advanced cervical carcinoma; however, the optimal scheduling and dosing have still not been established. This study was conducted to determine the maximum-tolerated dose (MTD) of cisplatin for daily administration during pelvic radiotherapy (RT).

METHODS:

Fourteen patients with locally advanced cervical carcinoma and 13 who required postoperative RT were registered. A low dose of cisplatin was given daily concurrently with RT. Cisplatin dosing was started at 6.0 mg/m(2)/day, which was incremented by 0.5 mg/m(2)/day. RT was delivered at 2 Gy/day to a total dose of 50 Gy. The MTD was defined as the dose level immediately below that causing dose-limiting toxicity (DLT) in over one-third of treated patients.

RESULTS:

Twenty-five patients were treated with a maximum of six escalating dose levels. In 22/25 patients (88%), cisplatin was administered continuously as planned without interruption. The MTD was determined to be 8 mg/m(2) and the DLT was indicated by the onset of neutropenia.

CONCLUSION:

Daily cisplatin, at 8 mg/m(2)/day, is a well-tolerated radiosensitizer in cervical carcinoma patients.

• Authors: Akira Mitsuhashi, Takashi Uno, Naotake Tanaka, Kiyomi Suzuka, Shinichi Tate, Koji Yamazawa, Hideo Matsui, Seiji Yamamoto, Hisao Ito, Souei Sekiya
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 96 Issue 1 Pg. 194-7 (Jan 2005) ISSN: 0090-8258 [Print] United States
• PMID: 15589600 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article)

Chemical References

• Antineoplastic Agents
• Cisplatin

Topics

• Adult
• Aged
• Antineoplastic Agents (adverse effects, therapeutic use)
• Cisplatin (adverse effects, therapeutic use)
• Combined Modality Therapy
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Humans
• Middle Aged
• Uterine Cervical Neoplasms (drug therapy, radiotherapy, surgery)