Pilot trial of cisplatin, radiation, and WR2721 in carcinoma of the uterine cervix: A New York gynecologic oncology group study

Scott Wadler, Jonathan J. Beitler, John S. Rubin, Hilda Haynes, Frances McGill, Alia Rozenblit, Gary Goldberg, Carmel Cohen, James Speyer, Carolyn Runowicz

Research output: Contribution to journalArticle

35 Scopus citations

Abstract

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 as-sessable. 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 × 5 schedule plus radiation therapy is 825 mg/m2/d for 5 days.

Original languageEnglish (US)
Pages (from-to)1511-1516
Number of pages6
JournalJournal of Clinical Oncology
Volume11
Issue number8
DOIs
StatePublished - Jan 1 1993

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Wadler, S., Beitler, J. J., Rubin, J. S., Haynes, H., McGill, F., Rozenblit, A., Goldberg, G., Cohen, C., Speyer, J., & Runowicz, C. (1993). Pilot trial of cisplatin, radiation, and WR2721 in carcinoma of the uterine cervix: A New York gynecologic oncology group study. Journal of Clinical Oncology, 11(8), 1511-1516. https://doi.org/10.1200/JCO.1993.11.8.1511