Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-24 @ 11:13 AM
Study NCT ID:
NCT00126620
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2005-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
University Health Network, Toronto
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: