Journal of Clinical Oncology, Vol 11, 1511-1516, Copyright © 1993 by American Society of Clinical Oncology
Pilot trial of cisplatin, radiation, and WR2721 in carcinoma of the uterine cervix: a New York Gynecologic Oncology Group study
S Wadler, JJ Beitler, JS Rubin, H Haynes, F McGill, A Rozenblit, G Goldberg, C Cohen, J Speyer and C Runowicz
Albert Einstein Cancer Center, Bronx, New York.
PURPOSE: A phase I trial of WR2721 was initiated to determine the maximal
safe dose for incorporation into a consecutive 5-day schedule of cisplatin
administered concurrently with radiation therapy in patients with cervical
cancer. PATIENTS AND METHODS: WR2721 was administered at 340 to 910 mg/m2/d
immediately before cisplatin. Cisplatin was administered at 20 mg/m2/d for
5 days every 3 weeks in combination with external-beam radiation therapy
and at 100 mg/m2 after each brachytherapy treatment. Pelvic radiation
consisted of external- beam therapy to a dose of 39.6 Gy, followed by
brachytherapy with cesium 137 tandem and ovoid insertions to deliver 80 Gy
to point A and 55 Gy to point B. RESULTS: Twenty patients were enrolled; 19
were assessable. The dose-limiting toxicity of WR2721 was hypotension. No
patients developed serious sequelae, but hypotension required a reduction
in the dose of WR2721 at the highest dose level tested. The major grade 3
or 4 toxicities included transient azotemia (five of 19), leukopenia (nine
of 19), vomiting (four of 19), and neurotoxicity (two of 19). One patient
experienced an anaphylactic reaction to cisplatin. CONCLUSION: The
recommended dose of WR2721 administered in conjunction with cisplatin on a
daily x 5 schedule plus radiation therapy is 825 mg/m2/d for 5 days.
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