Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281021
Status:
TERMINATED
Last Update Posted:
2018-03-29
First Post:
2006-01-23
Brief Title:
Second Line Erlotinib Tarceva Plus Digoxin in Non-Small Cell Lung Cancer
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Phase II Trial of Second Line Erlotinib Digoxin in Patients With Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis revealed that only 1 patient had a partial response
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the potential benefit of adding Digoxin to erlotinib Tarceva treatment for patients with non-small cell lung cancer
Detailed Description:
Non-small cell lung cancer NSCLC accounts for 80 of all lung cancer cases The majority of NSCLC patients have advanced disease at the time of diagnosis which usually requires treatment beyond standard first-line chemotherapy Until recently patients were limited in the number of options available for second-line treatment of NSCLC In 2004 erlotinib was approved by the FDA for second and third-line treatment of NSCLC Erlotinib is a cancer chemotherapy medication that slows the growth and spread of cancer cells in the body
Recent research suggests that a medication called Digoxin can sensitize cancer cells to respond better to chemotherapy Digoxin is normally used to treat certain heart conditions by helping the heart beat more strongly and regularly and is not approved by the FDA for the treatment of NSCLC Investigators hope that subject response rates to standard erlotinib therapy will be significantly improved by the addition of Digoxin
The purpose of this study is to determine the tumor response rate and overall survival of patients with non-small cell lung cancer treated with a daily regimen of erlotinib Tarceva plus Digoxin
Recent research suggests that a medication called Digoxin can sensitize cancer cells to respond better to chemotherapy Digoxin is normally used to treat certain heart conditions by helping the heart beat more strongly and regularly and is not approved by the FDA for the treatment of NSCLC Investigators hope that subject response rates to standard erlotinib therapy will be significantly improved by the addition of Digoxin
The purpose of this study is to determine the tumor response rate and overall survival of patients with non-small cell lung cancer treated with a daily regimen of erlotinib Tarceva plus Digoxin
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 |
|---|---|---|---|
| BCC-LUN-05-001 | OTHER | James Graham Brown Cancer Center Clinical Trials Office | None |