Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-03-18 @ 12:41 AM
Study NCT ID:
NCT00114192
Status:
COMPLETED
Last Update Posted:
2010-02-01
First Post:
2005-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel and Thalidomide as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2010-01
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 docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Thalidomide may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with thalidomide works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well giving docetaxel together with thalidomide works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the complete and partial response rates in patients with stage III or IV non-small cell lung cancer treated with docetaxel and thalidomide as second-line therapy.
Secondary
* Determine the toxicity of this regimen in these patients.
* Determine the response duration and survival of patients treated with this regimen.
* Determine the quality of life of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15. Patients also receive oral thalidomide once daily on days -7 to 28 for course 1 and on days 1-28 for all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after 6 courses of treatment may continue study treatment at the discretion of the investigator. Patients discontinuing docetaxel due to toxicity may continue treatment with thalidomide at the discretion of the investigator.
Quality of life is assessed at baseline, before each treatment course, after completion of study treatment, and then every 3 months thereafter.
After completion of study treatment, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Primary
* Determine the complete and partial response rates in patients with stage III or IV non-small cell lung cancer treated with docetaxel and thalidomide as second-line therapy.
Secondary
* Determine the toxicity of this regimen in these patients.
* Determine the response duration and survival of patients treated with this regimen.
* Determine the quality of life of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15. Patients also receive oral thalidomide once daily on days -7 to 28 for course 1 and on days 1-28 for all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after 6 courses of treatment may continue study treatment at the discretion of the investigator. Patients discontinuing docetaxel due to toxicity may continue treatment with thalidomide at the discretion of the investigator.
Quality of life is assessed at baseline, before each treatment course, after completion of study treatment, and then every 3 months thereafter.
After completion of study treatment, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?: