• M Morris, P J Eifel, T W Burke, M M McNamara, C Levenback, J J Kavanagh, and D M Gershenson.
• Department of Gynecologic Oncology, University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.
• Gynecol. Oncol. 1995 Apr 1; 57 (1): 72-8.

AbstractThe purpose of this study was to determine the maximum tolerated dose (MTD) and feasibility of treatment with sequential intra-arterial FUDR and cisplatin administered with concurrent whole pelvis radiation (XRT) to women with advanced cervical cancer. Sixteen patients with squamous carcinoma of the cervix were prospectively treated in a Phase I study. All tumors were stages IIb, IIIb, or IVa with diameters of > or = 7 cm. Patients underwent surgical staging with pelvic and paraortic lymphadenectomy with placement of bilateral intra-arterial catheters in the anterior division of the internal iliac arteries. The catheters terminated in separate subcutaneous ports. No patient had metastasis in the high common iliac or paraortic nodes. Patients received a planned course of 40-50 Gy whole pelvis XRT followed by indicated brachytherapy. During the first 2 weeks of whole pelvis XRT, patients received a 1-hr infusion of FUDR and during the second 2 weeks a 1-hr infusion of cisplatin, each delivered daily by external pump with the daily whole pelviS XRT fraction. Additional cisplatin was infused during brachytherapy. Five dose levels ranging from 6.5 to 27 mg/m2 daily for FUDR and from 2 to 8 mg/m2 daily for cisplatin were used. The MTD of FUDR and CDDP was dose level 4 (22.5 and 6.75 mg/m2, respectively). Dose-limiting toxicity was grade 3/4 nausea seen in three of four patients at dose level 5. No patient had neuro- or ototoxicity. There was no grade 4 myelosuppression. Eight patients had a complete response, and six had a partial response. Disease progressed in two. Mean follow-up was 22.4 months. At this writing, 10 patients had no evidence of disease, 2 were alive with disease, and 4 had died of disease. Median survival has not been reached. This is a well-tolerated regimen with significant activity that warrants further investigation at dose level 4.

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