Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305786
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2006-03-21
Brief Title:
Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Phase II Study of Oxaliplatin in Combination With Gemcitabine for 2 Line Treatment of NSCLC Patients With Advanced and Metastatic Disease
Status:
COMPLETED
Status Verified Date:
2016-12
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 oxaliplatin 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 oxaliplatin 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 gemcitabine together with oxaliplatin 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 efficacy and safety of gemcitabine hydrochloride and oxaliplatin as second-line chemotherapy in patients with stage IIIB or IV non-small cell lung cancer
Determine overall response in patients treated with this regimen
Secondary
Determine time to progression time to treatment failure and overall survival of these patients
Determine the type frequency severity timing and relatedness of all adverse events during treatment and for 30 days after completion of study treatment
Assess the quality of life of these patients
Determine the expression of RRM1 and ERCC1 in peripheral blood mononuclear cells from these patients
OUTLINE This is an open-label nonrandomized study
Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on days 1 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at the beginning of each course at the completion of study treatment and then every 6 weeks thereafter
After completion of study treatment patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the efficacy and safety of gemcitabine hydrochloride and oxaliplatin as second-line chemotherapy in patients with stage IIIB or IV non-small cell lung cancer
Determine overall response in patients treated with this regimen
Secondary
Determine time to progression time to treatment failure and overall survival of these patients
Determine the type frequency severity timing and relatedness of all adverse events during treatment and for 30 days after completion of study treatment
Assess the quality of life of these patients
Determine the expression of RRM1 and ERCC1 in peripheral blood mononuclear cells from these patients
OUTLINE This is an open-label nonrandomized study
Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on days 1 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at the beginning of each course at the completion of study treatment and then every 6 weeks thereafter
After completion of study treatment patients are followed every 3 months for up to 2 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WIRB-20050485 | OTHER | Western Institutional Review Board | None |
| SCCC-2004078 | OTHER | None | None |