Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114244
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2005-06-13
Brief Title:
Sorafenib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study of BAY 43-9006 in Combination With Gemcitabine in Metastatic Pancreatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This randomized phase II is studying how well giving sorafenib with or without gemcitabine works in treating patients with metastatic pancreatic cancer Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor 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 sorafenib together with gemcitabine may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the objective response rate in patients with metastatic pancreatic cancer treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabineBAY 43-9006 at progression
SECONDARY OBJECTIVES
I To determine the six month overall survival rate 3 month progression free survival rate time to tumor progression and overall survival of patients with metastatic pancreatic cancer treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabineBAY 43-9006 at progression
II To determine the safety profile of gemcitabine and BAY43-9006 in patients with metastatic pancreatic cancer and compared to those treated with single agent BAY 43-9006
III To determine whether mRNA expression levels of genes involved in the gemcitabine pathway RR dck dcd and genes involved in the Raf pathway cyclin D VEGFR2 p21 will predict for time to progression overall survival and response in patients with metastatic pancreatic cancer treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabineBAY 43-9006 at progression
IV To determine whether genomic polymorphisms of genes measured in peripheral blood mononuclear cells involved in the gemcitabine pathway RR and genes involved in the ras pathway VEGFR2 cyclin D p21 will predict for time to progression overall survival tumor response and toxicity in patients with advanced cancer of the pancreas treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabineBAY 43-9006 at progression
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral sorafenib twice daily on days 1-28 Patients experiencing disease progression cross over to Arm II
ARM II Patients receive oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1 8 and 15
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
I To determine the objective response rate in patients with metastatic pancreatic cancer treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabineBAY 43-9006 at progression
SECONDARY OBJECTIVES
I To determine the six month overall survival rate 3 month progression free survival rate time to tumor progression and overall survival of patients with metastatic pancreatic cancer treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabineBAY 43-9006 at progression
II To determine the safety profile of gemcitabine and BAY43-9006 in patients with metastatic pancreatic cancer and compared to those treated with single agent BAY 43-9006
III To determine whether mRNA expression levels of genes involved in the gemcitabine pathway RR dck dcd and genes involved in the Raf pathway cyclin D VEGFR2 p21 will predict for time to progression overall survival and response in patients with metastatic pancreatic cancer treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabineBAY 43-9006 at progression
IV To determine whether genomic polymorphisms of genes measured in peripheral blood mononuclear cells involved in the gemcitabine pathway RR and genes involved in the ras pathway VEGFR2 cyclin D p21 will predict for time to progression overall survival tumor response and toxicity in patients with advanced cancer of the pancreas treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabineBAY 43-9006 at progression
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral sorafenib twice daily on days 1-28 Patients experiencing disease progression cross over to Arm II
ARM II Patients receive oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1 8 and 15
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| N01CM62209 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62209 |
| NCI-2012-02835 | REGISTRY | None | None |
| PHII-50 | OTHER | None | None |
| 6576 | OTHER | None | None |