Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134069
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2005-08-22
Brief Title:
Sorafenib Cetuximab and Irinotecan in Treating Patients With Advanced or Metastatic Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Clinical Pharmacological and Biological Study of BAY 43-9006 in Combination With Cetuximab and Irinotecan in Patients With Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2014-04
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:
This phase III trial is studying the side effects and best dose of sorafenib when given together with cetuximab and irinotecan and to see how well they work in treating patients with advanced or metastatic colorectal cancer Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as cetuximab 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 Sorafenib and cetuximab may also stop tumor growth by blocking blood flow to the tumor Drugs used in chemotherapy such as irinotecan work in different ways to kill tumor cells either by killing the cells or by stopping them from dividing Giving sorafenib together with cetuximab and irinotecan may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the toxicity spectrum and dose-limiting toxic effects of sorafenib when combined with cetuximab and irinotecan in patients with advanced or metastatic colorectal cancer
II Determine the recommended phase II dose of sorafenib when combined with cetuximab and irinotecan in these patients
III Correlate the clinical activity of this regimen in terms of radiologic and positron emission tomography PET response with baseline extracellular signal-regulated kinase ERK expression as well as Kirsten rat sarcoma KRAS BRAF and other genetic properties of tumors in these patients
IV Determine the pharmacokinetics of this regimen in these patients V Correlate the pharmacodynamic effects of this regimen with baseline ERK expression as well as KRAS BRAF and other genetic properties of tumors in these patients
VI Correlate the pharmacodynamic effects of this regimen on mitogen-activated protein kinase MAPK status in peripheral blood mononuclear cells and on normal skin and oral mucosa with clinical parameters in these patients
OUTLINE This is a phase I dose-escalation study of sorafenib followed by a multicenter phase II study
PHASE I
COURSE 1 56 days Patients receive oral sorafenib once or twice daily on days 1-56 cetuximab IV over 1-2 hours on days 1 815 22 29 36 43 and 50 and irinotecan IV over 90 minutes on days 15 22 29 and 36
COURSE 2 AND ALL SUBSEQUENT COURSES 42 days Patients receive oral sorafenib once or twice daily on days 1-42 cetuximab IV over 1-2 hours on days 1 8 15 22 29 and 36 and irinotecan IV over 90 minutes on days 1 8 15 and 22 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
PHASE II Patients receive sorafenib at the MTD determined in phase I cetuximab and irinotecan as in phase I
After completion of study treatment patients are followed at 30 days
NOTE This trial was intended to be Phase III but the trial never continued to the Phase II portion
I Determine the toxicity spectrum and dose-limiting toxic effects of sorafenib when combined with cetuximab and irinotecan in patients with advanced or metastatic colorectal cancer
II Determine the recommended phase II dose of sorafenib when combined with cetuximab and irinotecan in these patients
III Correlate the clinical activity of this regimen in terms of radiologic and positron emission tomography PET response with baseline extracellular signal-regulated kinase ERK expression as well as Kirsten rat sarcoma KRAS BRAF and other genetic properties of tumors in these patients
IV Determine the pharmacokinetics of this regimen in these patients V Correlate the pharmacodynamic effects of this regimen with baseline ERK expression as well as KRAS BRAF and other genetic properties of tumors in these patients
VI Correlate the pharmacodynamic effects of this regimen on mitogen-activated protein kinase MAPK status in peripheral blood mononuclear cells and on normal skin and oral mucosa with clinical parameters in these patients
OUTLINE This is a phase I dose-escalation study of sorafenib followed by a multicenter phase II study
PHASE I
COURSE 1 56 days Patients receive oral sorafenib once or twice daily on days 1-56 cetuximab IV over 1-2 hours on days 1 815 22 29 36 43 and 50 and irinotecan IV over 90 minutes on days 15 22 29 and 36
COURSE 2 AND ALL SUBSEQUENT COURSES 42 days Patients receive oral sorafenib once or twice daily on days 1-42 cetuximab IV over 1-2 hours on days 1 8 15 22 29 and 36 and irinotecan IV over 90 minutes on days 1 8 15 and 22 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
PHASE II Patients receive sorafenib at the MTD determined in phase I cetuximab and irinotecan as in phase I
After completion of study treatment patients are followed at 30 days
NOTE This trial was intended to be Phase III but the trial never continued to the Phase II portion
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 |
|---|---|---|---|
| 07-0571 | OTHER | None | None |
| R21CA117125 | NIH | None | None |
| U01CA070095 | NIH | Colorado Multiple Institutional Review Board | httpsreporternihgovquickSearchU01CA070095 |