Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352443
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2006-07-13
Brief Title:
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkins Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase I Study Evaluating the Combination of Lapatinib GW572016 NSC-727989 and Everolimus RAD001 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-03
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 Lapatinib and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Everolimus may also stop the growth of cancer cells by blocking blood flow to the cancer Giving lapatinib together with everolimus may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of lapatinib and everolimus in treating patients with advanced solid tumors or non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of lapatinib and everolimus in treating patients with advanced solid tumors or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Estimate the maximum tolerated dose MTD of lapatinib and everolimus in patients with advanced solid tumors or non-Hodgkins lymphoma Part I
Investigate the pharmacokinetics of everolimus and lapatinib when given alone and in combination at the MTD determined in Part I Part II
Investigate the effects of everolimus and lapatinib when given alone and in combination on serum levels of vascular endothelial growth factor VEGF basic fibroblast growth factor bFGF matrix metalloproteinase MMP-2 and MMP-9 interleukin-6 IL-6 and tumor necrosis factor alpha TNF-α Part II
OUTLINE This is a multicenter dose-escalation study followed by a randomized study Initial patients enrolled on the study are treated in part I After the maximum tolerated dose MTD is determined in part I subsequent patients are enrolled and treated in part II
Part I Patients receive oral everolimus and oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of everolimus and lapatinib until the MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Part II Patients are randomized to 1 of 2 treatment arms Everolimus and lapatinib are administered at the MTD determined in part I
Arm I Patients receive oral everolimus once daily on days 1-28 Patients also receive oral lapatinib once daily on days 8-28 during the first course and on days 1-28 during all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral lapatinib once daily on days 1-28 Patients also receive oral everolimus once daily on days 8-28 during the first course and on days 1-28 during all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients in part II undergo blood collection periodically for correlative biomarker and pharmacokinetic studies
After finishing treatment patients are followed periodically for 28 days
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study
Estimate the maximum tolerated dose MTD of lapatinib and everolimus in patients with advanced solid tumors or non-Hodgkins lymphoma Part I
Investigate the pharmacokinetics of everolimus and lapatinib when given alone and in combination at the MTD determined in Part I Part II
Investigate the effects of everolimus and lapatinib when given alone and in combination on serum levels of vascular endothelial growth factor VEGF basic fibroblast growth factor bFGF matrix metalloproteinase MMP-2 and MMP-9 interleukin-6 IL-6 and tumor necrosis factor alpha TNF-α Part II
OUTLINE This is a multicenter dose-escalation study followed by a randomized study Initial patients enrolled on the study are treated in part I After the maximum tolerated dose MTD is determined in part I subsequent patients are enrolled and treated in part II
Part I Patients receive oral everolimus and oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of everolimus and lapatinib until the MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Part II Patients are randomized to 1 of 2 treatment arms Everolimus and lapatinib are administered at the MTD determined in part I
Arm I Patients receive oral everolimus once daily on days 1-28 Patients also receive oral lapatinib once daily on days 8-28 during the first course and on days 1-28 during all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral lapatinib once daily on days 1-28 Patients also receive oral everolimus once daily on days 8-28 during the first course and on days 1-28 during all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients in part II undergo blood collection periodically for correlative biomarker and pharmacokinetic studies
After finishing treatment patients are followed periodically for 28 days
PROJECTED ACCRUAL A total of 48 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 |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0528 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |