Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-30 @ 2:00 AM
Study NCT ID:
NCT00906061
Status:
UNKNOWN
Last Update Posted:
2009-05-21
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients
Sponsor:
Hospital Arnau de Vilanova
Organization:
Study Overview
Official Title:
Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2
Status:
UNKNOWN
Status Verified Date:
2009-05
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:
There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.
This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.
In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.
The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.
This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.
In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.
The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.
Detailed Description:
None
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?: