PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES
I. Determine the maximum tolerated doses of paclitaxel, cisplatin, and topotecan
administered together with or without filgrastim (G-CSF) in patients with newly diagnosed
advanced ovarian cancer.
II. Describe and quantitate the clinical toxic effects of combination chemotherapy with
paclitaxel, cisplatin, and topotecan with or without G-CSF.
III. Assess preliminary evidence of antitumor activity of this combination chemotherapy in
OUTLINE: This is a dose escalation study of topotecan.
Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan
IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning
on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicities.
Patients are followed as clinically indicated.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally tolerated doses (MTDs) of the combination of paclitaxel, Topotecan, and cisplatin administered without and with G-CSF based on dose-limiting toxicities (DLT) graded according to GOG Common Toxicity Criteria
Gynecologic Oncology Group
United States: Food and Drug Administration
|Gynecologic Oncology Group of Arizona||Phoenix, Arizona 85012|