Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00278070
Status:
COMPLETED
Last Update Posted:
2008-02-29
First Post:
2006-01-17
Brief Title:
Metronomic Oral Vinorelbine in Patients With Metastatic Tumors
Sponsor:
Hellenic Cooperative Oncology Group
Organization:
Hellenic Cooperative Oncology Group
Study Overview
Official Title:
Metronomic Vinorelbine in Patients With Metastatic Tumors Phase II Translational Study
Status:
COMPLETED
Status Verified Date:
2008-02
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:
Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three different doses 30 or 40 or 50 mg Vinorelbine will be administered orally at a metronomic schedule three times a week on Monday Wednesday and Friday
Detailed Description:
The purpose of this study is to define the biologically optimal dose of vinorelbine when administered at a metronomic dosing schema Metronomic chemotherapy refers to the close regular administration of minimally toxic doses of cytotoxic drugs with minimal or no drug-free breaks over prolonged periods Patients with recurrent or metastatic solid tumors are randomly assigned one of three different doses of oral vinorelbine 30 or 40 or 50 mg Treatment is administered three times a week Monday Wednesday and Friday continuously until disease progression or unacceptable toxicity or to a maximum of 24 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