TY - JOUR
T1 - Pilot trial of cisplatin, radiation, and WR2721 in carcinoma of the uterine cervix
T2 - A New York gynecologic oncology group study
AU - Wadler, Scott
AU - Beitler, Jonathan J.
AU - Rubin, John S.
AU - Haynes, Hilda
AU - McGill, Frances
AU - Rozenblit, Alia
AU - Goldberg, Gary
AU - Cohen, Carmel
AU - Speyer, James
AU - Runowicz, Carolyn
PY - 1993
Y1 - 1993
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.1993.11.8.1511
DO - 10.1200/JCO.1993.11.8.1511
M3 - Article
C2 - 8393096
AN - SCOPUS:0027169249
SN - 0732-183X
VL - 11
SP - 1511
EP - 1516
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 8
ER -