Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088894
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2004-08-04
Brief Title:
Gemcitabine With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Trial Of Gemcitabine Plus Bevacizumab NSC704865 IND7621 Versus Gemcitabine Plus Placebo In Patients With Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This randomized phase III trial is studying gemcitabine and bevacizumab to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor Combining gemcitabine with bevacizumab may kill more tumor cells It is not yet known whether gemcitabine is more effective with or without bevacizumab in treating pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine if combination chemotherapy with gemcitabine and bevacizumab achieves superior survival compared to gemcitabine and placebo in patients with previously untreated advanced pancreatic cancer
SECONDARY OBJECTIVES
I To compare the objective response rates duration of response progression free survival and toxicity of these two regimens in patients with advanced pancreatic cancer
II To measure baseline levels of VEGF and correlate with treatment outcome III To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment
IV To measure baseline and on treatment levels of coagulation and endothelial cell activation markers that may predict for thrombotic or bleeding risks related to treatment
V To generate protein expression profiles using a MALDI-TOF based platform from serum samples To analyze and compare protein expression profiles to elucidate ion peaks that differentiate patients who respond to therapy from patients who do not respond To identify proteins responsible for the differentially expressed ion peaks To develop quantitative assays for each of these proteins
VI To assess any differences in overall survival within the treatment arm gemcitabine bevacizumab between the two VEGF genotypic groups Group 1 denoted by individuals with CT or TT genotypes and Group 2 consisting of individuals with CC genotypes
VII To conduct an exploratory analysis of gene-toxicity gene-response and gene-survival relationships for the various polymorphisms described in the genes implicated in gemcitabine pharmacology CDA DCK DCTD SLC29A1 SLC28A1 SLC29A2 An exploratory quantitative interaction between the genotypes group 1 or 2 and the treatment arms gemcitabine bevacizumab or gemcitabine placebo in predicting overall survival will also be evaluated
VIII To identify specific SNPs and genetic variation that are associated with differences among patients in the risk of toxicity
IX To compare the effects of gemcitabine bevacizumab versus gemcitabine placebo on resource utilization cost and utilities and if applicable to make estimates of marginal cost-utility
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to ECOG performance status 0-1 vs 2 disease extent metastatic vs locally advanced and prior radiotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15
Arm II Patients receive gemcitabine IV as in arm I and placebo IV over 30-90 minutes on days 1 and 15
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 590 patients 295 per treatment arm will be accrued for this study within 268 months
I To determine if combination chemotherapy with gemcitabine and bevacizumab achieves superior survival compared to gemcitabine and placebo in patients with previously untreated advanced pancreatic cancer
SECONDARY OBJECTIVES
I To compare the objective response rates duration of response progression free survival and toxicity of these two regimens in patients with advanced pancreatic cancer
II To measure baseline levels of VEGF and correlate with treatment outcome III To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment
IV To measure baseline and on treatment levels of coagulation and endothelial cell activation markers that may predict for thrombotic or bleeding risks related to treatment
V To generate protein expression profiles using a MALDI-TOF based platform from serum samples To analyze and compare protein expression profiles to elucidate ion peaks that differentiate patients who respond to therapy from patients who do not respond To identify proteins responsible for the differentially expressed ion peaks To develop quantitative assays for each of these proteins
VI To assess any differences in overall survival within the treatment arm gemcitabine bevacizumab between the two VEGF genotypic groups Group 1 denoted by individuals with CT or TT genotypes and Group 2 consisting of individuals with CC genotypes
VII To conduct an exploratory analysis of gene-toxicity gene-response and gene-survival relationships for the various polymorphisms described in the genes implicated in gemcitabine pharmacology CDA DCK DCTD SLC29A1 SLC28A1 SLC29A2 An exploratory quantitative interaction between the genotypes group 1 or 2 and the treatment arms gemcitabine bevacizumab or gemcitabine placebo in predicting overall survival will also be evaluated
VIII To identify specific SNPs and genetic variation that are associated with differences among patients in the risk of toxicity
IX To compare the effects of gemcitabine bevacizumab versus gemcitabine placebo on resource utilization cost and utilities and if applicable to make estimates of marginal cost-utility
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to ECOG performance status 0-1 vs 2 disease extent metastatic vs locally advanced and prior radiotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15
Arm II Patients receive gemcitabine IV as in arm I and placebo IV over 30-90 minutes on days 1 and 15
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 590 patients 295 per treatment arm will be accrued for this study within 268 months
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-80303 | None | None | None |
| CDR0000377542 | None | None | None |