Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193570
Status:
COMPLETED
Last Update Posted:
2009-01-23
First Post:
2005-09-12
Brief Title:
Topotecan in Combination With Docetaxel in Refractory andor Advanced Solid Tumors
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase I Study of Topotecan in Combination With Docetaxel in Patients With Refractory andor Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2009-01
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:
This phase I study will characterize the safety tolerability and maximum tolerated dose and dose-limiting toxicity of weekly bolus Topotecan when administered in combination with to different dosing regimens of docetaxel We will also evaluate any anti-tumor activity of the combination regimen
Detailed Description:
Upon determination of eligibility patients will be randomly assigned to one of two treatment arms
For ever 2 patients treated 1 will receive treatment A Paclitaxel Carboplatin Gemcitabine and 1 will receive treatment B Gemcitabine Vinorelbine The study is not blinded so both the patient and the doctor will know which treatment has been assigned
Upon determination of eligibility patients will be receive
Docetaxel Topotecan
In order to determine the most appropriate dosing regimen to progress into future phase II trials two different dosing schedules of Topotecan and docetaxel will be utilized
For ever 2 patients treated 1 will receive treatment A Paclitaxel Carboplatin Gemcitabine and 1 will receive treatment B Gemcitabine Vinorelbine The study is not blinded so both the patient and the doctor will know which treatment has been assigned
Upon determination of eligibility patients will be receive
Docetaxel Topotecan
In order to determine the most appropriate dosing regimen to progress into future phase II trials two different dosing schedules of Topotecan and docetaxel will be utilized
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 |
|---|---|---|---|
| 104864652 | None | None | None |