Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438204
Status:
TERMINATED
Last Update Posted:
2021-04-13
First Post:
2007-02-20
Brief Title:
Pemetrexed Disodium Gemcitabine and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Pemetrexed Gemcitabine and Bevacizumab Every Two Weeks in Chemotherapy-Naive Patients With Stages IIIBIV Non- Squamous Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
All data collection has completed
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 Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving pemetrexed disodium and gemcitabine together with bevacizumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving pemetrexed disodium and gemcitabine together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving pemetrexed disodium and gemcitabine together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of pemetrexed disodium gemcitabine hydrochloride and bevacizumab in chemotherapy-naïve patients with stage IIIB or IV nonsquamous cell non-small cell lung cancer
Secondary
Determine the response rate in patients treated with this regimen
Determine the time to treatment failure in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive pemetrexed disodium IV over 10 minutes gemcitabine hydrochloride IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients may then receive bevacizumab alone in the absence of disease progression or unacceptable toxicity
After the completion of study treatment patients are followed periodically for 6 months
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Primary
Determine the efficacy of pemetrexed disodium gemcitabine hydrochloride and bevacizumab in chemotherapy-naïve patients with stage IIIB or IV nonsquamous cell non-small cell lung cancer
Secondary
Determine the response rate in patients treated with this regimen
Determine the time to treatment failure in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive pemetrexed disodium IV over 10 minutes gemcitabine hydrochloride IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients may then receive bevacizumab alone in the absence of disease progression or unacceptable toxicity
After the completion of study treatment patients are followed periodically for 6 months
PROJECTED ACCRUAL A total of 42 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 |
|---|---|---|---|
| WSU-036806MP4F | OTHER | Wayne State University - Human Investigation Committee | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-2005-008 | OTHER | None | None |