CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY FOR ADVANCED ENDOMETRIAL CARCINOMA - A PHASE-II STUDY OF THE GYNECOLOGIC-ONCOLOGY-GROUP

Patients with advanced or recurrent endometrial cancer of any cell typ e having measurable disease have been entered into this study to deter mine the effectiveness and toxicity of circadian-timed doxorubicin-cis platin chemotherapy. This Phase II study involved no randomization wit h treatment initiated with doxorubicin 60 mg/m2 over 30 minutes at 6:0 0 a.m., followed by cisplatin 60 mg/m2 over 30 minutes at 6:00 p.m. ev ery 28 days. Treatment was continued for eight cycles or to a maximum tolerable doxorubicin dose of 480 mg/m2 for patients without progressi on. Thereafter, responders continued on cisplatin alone. A review of 3 0 evaluable patients showed 6 (20%) complete responses, 12 (40%) parti al responses, and 7 (23%) with stable disease. The number of treatment courses ranged from 2 to 14 with a median of 6.5. the median white bl ood cell nadir for the 27 patients experiencing leukopenia was 1,600/m m3 (range: 300-3,600/mm3). For the 16 patients experiencing thrombocyt openia the median nadir was 48,500/mm3 (range: 8,000-138,000/mm3. Ther e were no treatment-related deaths. Circadian-timed delivery of doxoru bicin-cisplatin chemotherapy was reasonably well tolerated and demonst rated notable response rates in patients with advanced or recurrent en dometrial carcinoma.