NCT00002913

Paclitaxel, Cisplatin, and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer

PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Brenner Tumor
• Ovarian Clear Cell Cystadenocarcinoma
• Ovarian Endometrioid Adenocarcinoma
• Ovarian Mixed Epithelial Carcinoma
• Ovarian Mucinous Cystadenocarcinoma
• Ovarian Serous Cystadenocarcinoma
• Ovarian Undifferentiated Adenocarcinoma
• Stage III Ovarian Epithelial Cancer
• Stage IV Ovarian Epithelial Cancer

Interventions

Type	Name	Description
DRUG	paclitaxel	Given IV
DRUG	cisplatin	Given IV
DRUG	topotecan hydrochloride	Given IV
BIOLOGICAL	filgrastim	Given SC

Timeline

• Start date: 1996-12-01
• Primary completion: 2007-07-01
• First posted: 2003-01-27
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States