Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-02 @ 6:56 AM
Study NCT ID:
NCT00345059
Status:
TERMINATED
Last Update Posted:
2016-01-14
First Post:
2006-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer
Sponsor:
National Cancer Institute, Naples
Organization:
Study Overview
Official Title:
Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISTAL-2
Brief Summary:
The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.
Detailed Description:
This study is for patients with previously diagnosed advanced non small cell lung cancer (NSCLC, stage IIIb or IV) who had progression of their disease during or after first-line therapy containing platinum. Patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens:
* docetaxel
* docetaxel + vinorelbine
* docetaxel + gemcitabine
* docetaxel + capecitabine
* docetaxel
* docetaxel + vinorelbine
* docetaxel + gemcitabine
* docetaxel + capecitabine
Study Oversight
Has Oversight DMC:
False
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?: