Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287885
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2006-02-06
Brief Title:
Docetaxel in Treating Patients With Refractory or Recurrent Advanced Gynecologic Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer
Status:
COMPLETED
Status Verified Date:
2017-11
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:
RATIONALE Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor Giving daily doses of docetaxel may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel in treating patients with refractory or recurrent advanced gynecologic cancer
PURPOSE This phase I trial is studying the side effects and best dose of docetaxel in treating patients with refractory or recurrent advanced gynecologic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
Secondary
Determine the response rate in patients treated with this drug
Determine the pharmacokinetics associated with this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive docetaxel intravenously IV over 1-2 minutes daily for up to 6 months in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed every 3 months
Primary
Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
Secondary
Determine the response rate in patients treated with this drug
Determine the pharmacokinetics associated with this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive docetaxel intravenously IV over 1-2 minutes daily for up to 6 months in the absence of unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed every 3 months
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 |
|---|---|---|---|
| 0307M50626 | OTHER | IRB University of Minnesota | None |
| UMN-WCC-35 | OTHER | None | None |