RANDOMIZED STUDY OF DOXORUBICIN PLUS CISPLATIN VS CIRCADIAN-TIMED DOXORUBICIN

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Women with stage III, IV or recurrent endometrial carcinoma previously not treated with chemotherapy are eligible for the study. The aims of this study are to determine if circadian-timed doxorubicin- cisplatin chemotherapy offers significant improvement in the frequency of objective response, the duration of progression-free interval and the length of survival as compared to standard doxorubicin-cisplatin chemotherapy and to determine if there are any significant differences in toxicity between circadian-timed delivery of doxorubicin-cisplatin, chemotherapy versus standard delivery of doxorubicin-cisplatin chemotherapy. This study is a randomized study and randomization with equal probabilities will be carried out to each of the two treatment regimens balancing the sequence of assigned regimens within all GOG institutions participating in this study. I would estimate the accrual of twenty patients from this institution.