Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002913
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
1999-11-01
Brief Title:
Paclitaxel Cisplatin and Topotecan With or Without Filgrastim in Treating Patients With Newly Diagnosed Stage III or Stage IV Epithelial Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 persons 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-9602 | None | None | None |
| U10CA027469 | NIH | None | None |
| CDR0000065286 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA027469 |