title: Circadian-timed combination doxorubicin-cisplatin chemotherapy for advanced endometrial carcinoma. A phase II study of the Gynecologic Oncology Group.
abstract: Patients with advanced or recurrent endometrial cancer of any cell type having measurable disease have been entered into this study to determine the effectiveness and toxicity of circadian-timed doxorubicin-cisplatin chemotherapy. This Phase II study involved no randomization with treatment initiated with doxorubicin 60 mg/m2 over 30 minutes at 6:00 a.m., followed by cisplatin 60 mg/m2 over 30 minutes at 6:00 p.m. every 28 days. Treatment was continued for eight cycles or to a maximum tolerable doxorubicin dose of 480 mg/m2 for patients without progression. Thereafter, responders continued on cisplatin alone. A review of 30 evaluable patients showed 6 (20%) complete responses, 12 (40%) partial 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 blood cell nadir for the 27 patients experiencing leukopenia was 1,600/mm3 (range: 300-3,600/mm3) For the 16 patients experiencing thrombocytopenia the median nadir was 48,500/mm3 (range: 8,000-138,000/mm3). There were no treatment-related deaths. Circadian-timed delivery of doxorubicin-cisplatin chemotherapy was reasonably well tolerated and demonstrated notable response rates in patients with advanced or recurrent endometrial carcinoma.
authors.affiliation: Section of Gynecologic Oncology, Bowman Gray School of Medicine of Wake Forest University, Winston-Salem, North Carolina 27103.
authors.forename: R J
authors.initials: RJ
authors.lastname: Barrett
authors.forename: J A
authors.initials: JA
authors.lastname: Blessing
authors.forename: H D
authors.initials: HD
authors.lastname: Homesley
authors.forename: L
authors.initials: L
authors.lastname: Twiggs
authors.forename: K D
authors.initials: KD
authors.lastname: Webster
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D002940:Circadian Rhythm; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D012074:Remission Induction
chemical_list: D004317:Doxorubicin; D002945:Cisplatin