Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075517
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2004-01-09
Brief Title:
Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_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 gemcitabine and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die Giving more than one drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel
Secondary
Determine the progression-free and overall survival of patients treated with this regimen
Determine the tolerance profile of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a nonrandomized multicenter study
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1 Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after courses 6 and 12 and then every 3 months thereafter
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study within 18 months
Primary
Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel
Secondary
Determine the progression-free and overall survival of patients treated with this regimen
Determine the tolerance profile of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a nonrandomized multicenter study
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1 Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after courses 6 and 12 and then every 3 months thereafter
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| FRE-GERCOR-DOCEGEM-B00-2 | None | None | None |
| EU-20331 | None | None | None |