Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280735
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2006-01-19
Brief Title:
Ph II Adjuvant CarboplatinDocetaxel in Curatively Resected Stage I-IIIA NSCLC
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial Exploring the Feasibility of Adjuvant CarboplatinDocetaxel in Curatively Resected Stage I-IIIA Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-06
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 carboplatin 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 carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I stage II or stage III non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I stage II or stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I II or IIIA non-small cell lung cancer
Secondary
Determine the toxicity of this regimen in these patients
Determine the survival patterns of patients treated with this regimen
Assess the patterns of recurrence in patients treated with this regimen
OUTLINE Patients receive carboplatin IV on day 1 and docetaxel IV on day 1 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
Primary
Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I II or IIIA non-small cell lung cancer
Secondary
Determine the toxicity of this regimen in these patients
Determine the survival patterns of patients treated with this regimen
Assess the patterns of recurrence in patients treated with this regimen
OUTLINE Patients receive carboplatin IV on day 1 and docetaxel IV on day 1 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
Study Oversight
Has Oversight DMC:
None
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?:
None