Ignite Creation Date:
2024-05-05 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00771953
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2008-10-10
Brief Title:
0822GCC Phase 2 Study of Efficacy and Safety of ApricoxibPlacebo With Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
0822GCC Randomized Double-Blind Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Either Docetaxel or Pemetrexed in Non-Small Cell Lung Cancer Patients
Status:
COMPLETED
Status Verified Date:
2019-10
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 primary objective is to determine the anti-tumor activity of the combination of apricoxib either docetaxel APDC or pemetrexed APPE compared with placebo either docetaxel PDC or pemetrexed PPE as measured by progression free survival in patients with Stage IIIb pleural effusionor Stage IV non-small cell lung cancer NSCLC
Detailed Description:
Patients diagnosed with advanced non-small cell lung cancer that has not responded to platinum-based chemotherapy are eligible to particvpate in this study
Current standard treatments for this type of lung cancer are generally not effective in preventing the cancer from growing The purpose of this study is to see if adding the drug apricoxib to standard chemotherapy is effective in treting NSCLC Apricoxib is an investigational drug Investigational means that it is not approved by the Food and Drug Administration FDA Laboratory studies suggest that apricoxib may be useful in the treatment of cancer This is seen particularly when it is combined with chemotherapy drugs However this has not been proven in humans
Laboratory evidence indicates that apricoxib may benefit patients whose disease over-produces a substance called COX-2 COX-2 can be detected in the urine as a substance called PGE-M prostaglandin E metabolite It is thought that patients who have a PGE-M level in the urine that decreases by at least half after taking apricoxib may benefit more than patients whose urine PGE-M decreases by less than half after apricoxib
This study evaluated whether adding apricoxib to standard chemotherapy treatment will improve outcomes in patients with non-small cell lung cancer whose urine PGE-M decreases at least 50 after taking apricoxib Apricoxib or placebo was added to either docetaxel or pemetrexed treatment
Current standard treatments for this type of lung cancer are generally not effective in preventing the cancer from growing The purpose of this study is to see if adding the drug apricoxib to standard chemotherapy is effective in treting NSCLC Apricoxib is an investigational drug Investigational means that it is not approved by the Food and Drug Administration FDA Laboratory studies suggest that apricoxib may be useful in the treatment of cancer This is seen particularly when it is combined with chemotherapy drugs However this has not been proven in humans
Laboratory evidence indicates that apricoxib may benefit patients whose disease over-produces a substance called COX-2 COX-2 can be detected in the urine as a substance called PGE-M prostaglandin E metabolite It is thought that patients who have a PGE-M level in the urine that decreases by at least half after taking apricoxib may benefit more than patients whose urine PGE-M decreases by less than half after apricoxib
This study evaluated whether adding apricoxib to standard chemotherapy treatment will improve outcomes in patients with non-small cell lung cancer whose urine PGE-M decreases at least 50 after taking apricoxib Apricoxib or placebo was added to either docetaxel or pemetrexed treatment
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 |
|---|---|---|---|
| UMGCC 0822 | OTHER | University of Maryland Greenebaum Cancer Center | None |