Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407550
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2006-12-04
Brief Title:
Pemetrexed Disodium and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Randomized Phase II Study of ALIMTA Pemetrexed and GEMZAR Gemcitabine Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-04
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 Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving pemetrexed disodium together with gemcitabine may kill more tumor cells
PURPOSE This randomized phase II trial is studying two different schedules of pemetrexed disodium and gemcitabine to compare how well they work in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This randomized phase II trial is studying two different schedules of pemetrexed disodium and gemcitabine to compare how well they work in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare response rates in patients with stage IIIB or IV non-small cell lung cancer treated with two different treatment schedules of pemetrexed disodium and gemcitabine hydrochloride
Secondary
Compare time-to-event efficacy variables in patients treated with these regimens
Compare progression-free and overall survival of patients treated with these regimens
Determine the overall toxicity of these regimens in these patients
OUTLINE This is a multicenter open-label randomized study Patients are stratified according to disease stage IIIB vs IV and ECOG performance status 0 vs 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study
Primary
Compare response rates in patients with stage IIIB or IV non-small cell lung cancer treated with two different treatment schedules of pemetrexed disodium and gemcitabine hydrochloride
Secondary
Compare time-to-event efficacy variables in patients treated with these regimens
Compare progression-free and overall survival of patients treated with these regimens
Determine the overall toxicity of these regimens in these patients
OUTLINE This is a multicenter open-label randomized study Patients are stratified according to disease stage IIIB vs IV and ECOG performance status 0 vs 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1 Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 80 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 |
|---|---|---|---|
| P30CA015083 | NIH | None | None |
| RC0524 | OTHER | None | None |
| 06-002282 | OTHER | None | None |
| H3E-US-S061 | OTHER | Lilly Protocol | httpsreporternihgovquickSearchP30CA015083 |