Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-05 @ 6:26 PM
Study NCT ID:
NCT01671332
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2012-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Status:
COMPLETED
Status Verified Date:
2020-05
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:
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
Detailed Description:
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
Secondary objectives include:
* To compare response rate of patients in both treatment arms
* To compare overall survival of patients in both treatment arms
* To compare toxicity in both treatment arms
* To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes
Secondary objectives include:
* To compare response rate of patients in both treatment arms
* To compare overall survival of patients in both treatment arms
* To compare toxicity in both treatment arms
* To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: