Ovarian Endometrioid Adenocarcinoma Clinical Trial
Official title:
PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES
Phase I trial to study the effectiveness of paclitaxel, cisplatin, and topotecan with or without filgrastim in treating patients who have newly diagnosed stage III or stage IV epithelial ovarian cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy
PRIMARY OBJECTIVES:
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
these patients.
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
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