A Dose-Escalating Study of Weekly Bolus Topotecan in Previously Treated Ovarian Cancer Patients

Gynecologic oncology group trials of chemotherapy for metastatic and recurrent cervical cancer

“…For example, in protocols 179 and 204, the dose of topotecan, 0.75 mg/m 2 /d over 72 hours, is lower than that used in the GOG phase II study, (protocol 76U), and the higher dose given over 5 days needs to be investigated in a phase III trial. Furthermore, weekly topotecan [73] may result in lower hematologic toxicity, and a weekly regimen containing both topotecan and cisplatin should be considered. Finally, Gimatecan (Novartis, East Hanover, NJ) is a newly developed topoisomerase I inhibitor analog of topotecan that can be administered orally, suggesting that pharmacokinetic and bioavailability data in this patient population would be of substantial merit to study.…”

Emerging Role of Weekly Topotecan in Recurrent Small Cell Lung Cancer

“…More recent trials have used shorter and more convenient 30-minute i.v. bolus injections and attempted to increase dose intensity up to 10 mg/m 2 in one trial in patients with advanced malignancies [23][24][25][26]. These regimens have been well tolerated and have demonstrated activity against sarcomas, prostate cancer, and ovarian cancer in phase I trials [24,26].…”

“…Further studies in patients with ovarian cancer suggest that higher-dose weekly bolus topotecan regimens appear to be more active than this relatively low-dose regimen. Despite the increases in dose intensity, these regimens maintain a low incidence of grade 3 or 4 hematologic toxicities, and ORRs have ranged from 9%-32%, with SD rates from 19%-45% [22,23,29,30].…”

A Phase I trial of weekly docetaxel and topotecan for solid tumors

“…On closer scrutiny, the clinical benefit rate (partial response'stable disease, PR'SD) was similar and achieved with less toxicity. In a separate study in ovarian cancer, Homesley et al [13] demonstrated that anti-tumor activity was higher at doses of topotecan 2 mg/m 2 weekly compared to doses B2 mg/m 2 weekly. There was no dose-limiting myelotoxicity.…”