Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126620
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2005-08-02
Brief Title:
Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase I Study of BAY 43-9006 Sorafenib in Combination With OSI-774 Erlotinib Tarceva in Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-07
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 Sorafenib and erlotinib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth
PURPOSE This phase I trial is studying the side effects and best dose of sorafenib and erlotinib in treating patients with metastatic or unresectable solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of sorafenib and erlotinib in treating patients with metastatic or unresectable solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and recommended phase II dose of sorafenib and erlotinib in patients with metastatic or unresectable solid tumors
Secondary
Determine the optimal biologically effective dose of this regimen that will lead to hypophosphorylation of epidermal growth factor receptor EGFR ERK Akt and vascular endothelial growth factor receptor VEGFR and inhibition of angiogenesis and apoptosis with tolerable toxicity in these patients
Correlate the pharmacokinetic profiles of this regimen with toxicity and biological activity in these patients
Determine preliminarily the antitumor activity of this regimen in these patients
Correlate phosphorylation status of EGFR ERK Akt and VEGFR with antitumor activity of this regimen in these patients
OUTLINE This is a multicenter open label non-randomized dose-escalation study
Patients receive oral sorafenib alone once or twice daily on days -6 to 0 Patients then receive oral sorafenib once or twice daily and oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
NOTE Not considered part of course 1 considered a run-in period only
Cohorts of 3-6 patients receive escalating doses of sorafenib and erlotinib 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 An additional 10 patients are treated at the MTD
After completion of study treatment patients are followed at 4 weeks and then at least annually thereafter
PROJECTED ACCRUAL A total of 16-28 patients will be accrued for this study within 5-14 months
Primary
Determine the maximum tolerated dose and recommended phase II dose of sorafenib and erlotinib in patients with metastatic or unresectable solid tumors
Secondary
Determine the optimal biologically effective dose of this regimen that will lead to hypophosphorylation of epidermal growth factor receptor EGFR ERK Akt and vascular endothelial growth factor receptor VEGFR and inhibition of angiogenesis and apoptosis with tolerable toxicity in these patients
Correlate the pharmacokinetic profiles of this regimen with toxicity and biological activity in these patients
Determine preliminarily the antitumor activity of this regimen in these patients
Correlate phosphorylation status of EGFR ERK Akt and VEGFR with antitumor activity of this regimen in these patients
OUTLINE This is a multicenter open label non-randomized dose-escalation study
Patients receive oral sorafenib alone once or twice daily on days -6 to 0 Patients then receive oral sorafenib once or twice daily and oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
NOTE Not considered part of course 1 considered a run-in period only
Cohorts of 3-6 patients receive escalating doses of sorafenib and erlotinib 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 An additional 10 patients are treated at the MTD
After completion of study treatment patients are followed at 4 weeks and then at least annually thereafter
PROJECTED ACCRUAL A total of 16-28 patients will be accrued for this study within 5-14 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 |
|---|---|---|---|
| CDR0000437855 | REGISTRY | None | None |
| NCI-7178 | Registry Identifier | PDQ Physician Data Query | None |