Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006088
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2000-08-03
Brief Title:
Vinorelbine in Treating Patients With Metastatic or Advanced Solid Tumors
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Absolute Bioavailability Study of Oral NAVELBINE Vinorelbine Tartrate in Patients With Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2000-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Randomized phase I trial to compare the effectiveness of two different regimens of vinorelbine in treating patients who have metastatic or advanced solid tumors
PURPOSE Randomized phase I trial to compare the effectiveness of two different regimens of vinorelbine in treating patients who have metastatic or advanced solid tumors
Detailed Description:
OBJECTIVES I Compare the pharmacokinetic profiles of vinorelbine administered intravenously on day 1 and orally on day 8 vs the reverse order in patients with metastatic or advanced solid tumors II Determine the intersubject variability in the pharmacokinetics of oral vinorelbine III Compare the safety profiles of oral vs intravenous vinorelbine in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive vinorelbine IV over 20 minutes on day 1 and oral vinorelbine on day 8 Arm II Patients receive oral vinorelbine on day 1 and vinorelbine IV over 20 minutes on day 8 Treatment continues in both arms in the absence of unacceptable toxicity or disease progression Patients are followed for 28 days
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive vinorelbine IV over 20 minutes on day 1 and oral vinorelbine on day 8 Arm II Patients receive oral vinorelbine on day 1 and vinorelbine IV over 20 minutes on day 8 Treatment continues in both arms in the absence of unacceptable toxicity or disease progression Patients are followed for 28 days
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1826 | None | None | None |
| MCC-11982 | None | None | None |
| GW-VIN10003 | None | None | None |