Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00616031
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2008-02-14
Brief Title:
Paclitaxel and Carboplatin With or Without Nitroglycerin in Treating Patients With Previously Untreated Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Kyoto University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Multinational and Multicenter Randomized Controlled Study of Paclitaxel and Carboplatin With vs Without Nitroglycerin in Patients With Untreated Advanced Non-small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
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 such as paclitaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Nitroglycerin may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs
PURPOSE This phase II randomized trial is studying how well giving nitroglycerin together with paclitaxel and carboplatin works and compares it to giving paclitaxel and carboplatin alone in treating patients with previously untreated stage III or stage IV non-small cell lung cancer
PURPOSE This phase II randomized trial is studying how well giving nitroglycerin together with paclitaxel and carboplatin works and compares it to giving paclitaxel and carboplatin alone in treating patients with previously untreated stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
To evaluate tumor response rate and safety of nitroglycerin as a potentiator of anticancer combination therapy comprising paclitaxel and carboplatin in patients with previously untreated stage IIIB or IV non-small cell lung cancer
OUTLINE This is a multicenter randomized controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive nitroglycerin paclitaxel and carboplatin
Arm II Patients receive paclitaxel and carboplatin In both arms treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity
To evaluate tumor response rate and safety of nitroglycerin as a potentiator of anticancer combination therapy comprising paclitaxel and carboplatin in patients with previously untreated stage IIIB or IV non-small cell lung cancer
OUTLINE This is a multicenter randomized controlled study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive nitroglycerin paclitaxel and carboplatin
Arm II Patients receive paclitaxel and carboplatin In both arms treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TRIC-C157 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000584254 | REGISTRY | None | None |