Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT00278460
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2006-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent stage III 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 recurrent stage III or stage IV non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel.
* Determine the overall and progression-free survival of patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
Secondary
* Determine the duration of response in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
Primary
* Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel.
* Determine the overall and progression-free survival of patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
Secondary
* Determine the duration of response in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
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?: