Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227708
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2005-09-26
Brief Title:
Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70
Status:
COMPLETED
Status Verified Date:
2020-02
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 Chemotherapy drugs may have different effects in older patients
PURPOSE This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer
PURPOSE This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the quality of life of older patients with locally advanced or metastatic non-small cell lung cancer treated with docetaxel
Secondary
Determine the response rate in patients treated with this drug
Determine the overall survival and progression-free survival of patients treated with this drug
Determine the mood status and autonomy of activity of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive docetaxel IV twice in week 1 Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed during study therapy in weeks 3-4 7-8 and 11-12 and then at 6 and 12 months after completion of study treatment
PROJECTED ACCRUAL A total of 58 patients will be accrued for this study
Primary
Determine the quality of life of older patients with locally advanced or metastatic non-small cell lung cancer treated with docetaxel
Secondary
Determine the response rate in patients treated with this drug
Determine the overall survival and progression-free survival of patients treated with this drug
Determine the mood status and autonomy of activity of patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive docetaxel IV twice in week 1 Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed during study therapy in weeks 3-4 7-8 and 11-12 and then at 6 and 12 months after completion of study treatment
PROJECTED ACCRUAL A total of 58 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20521 | None | None | None |
| FRE-FNCLCC-GERICO-050501 | None | None | None |