Rj. Barrett et al., CIRCADIAN-TIMED COMBINATION DOXORUBICIN-CISPLATIN CHEMOTHERAPY FOR ADVANCED ENDOMETRIAL CARCINOMA - A PHASE-II STUDY OF THE GYNECOLOGIC-ONCOLOGY-GROUP, American journal of clinical oncology, 16(6), 1993, pp. 494-496
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.