Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425386
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2007-01-19
Brief Title:
Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Dose Escalation Phase II Study of Sunitinib Plus Erlotinib in Advanced Renal Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-05
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 Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Giving sunitinib together with erlotinib may kill more tumor cells
PURPOSE This phase II trial is studying the best dose of erlotinib when given together with sunitinib and to see how well they work in treating patients with unresectable or metastatic kidney cancer
PURPOSE This phase II trial is studying the best dose of erlotinib when given together with sunitinib and to see how well they work in treating patients with unresectable or metastatic kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of erlotinib hydrochloride when administered with sunitinib malate in patients with unresectable or metastatic renal cell carcinoma
Determine the 8-month progression-free survival of patients treated with this regimen
Secondary
Determine the safety of sunitinib malate and erlotinib hydrochloride in these patients
Determine the duration of response in these patients
Determine the proportion of patients whose best overall response is complete response partial response stable disease or progressive disease
Determine the overall survival of patients treated with this regimen
Determine the maximum percent reduction in tumor measurement in patients treated with this regimen
Collect blood and tissue from these patients for future correlative studies
OUTLINE This is an open-label multicenter dose-escalation study of erlotinib hydrochloride
Patients receive oral sunitinib malate once daily on days 1-28 and oral erlotinib hydrochloride once daily on days 1-42 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 33 of patients experience dose-limiting toxicity Once the MTD is determined patients are treated with erlotinib hydrochloride at the MTD and sunitinib malate
Patients undergo blood and tumor specimen collection periodically during study for future correlative studies
PROJECTED ACCRUAL A total of 49 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of erlotinib hydrochloride when administered with sunitinib malate in patients with unresectable or metastatic renal cell carcinoma
Determine the 8-month progression-free survival of patients treated with this regimen
Secondary
Determine the safety of sunitinib malate and erlotinib hydrochloride in these patients
Determine the duration of response in these patients
Determine the proportion of patients whose best overall response is complete response partial response stable disease or progressive disease
Determine the overall survival of patients treated with this regimen
Determine the maximum percent reduction in tumor measurement in patients treated with this regimen
Collect blood and tissue from these patients for future correlative studies
OUTLINE This is an open-label multicenter dose-escalation study of erlotinib hydrochloride
Patients receive oral sunitinib malate once daily on days 1-28 and oral erlotinib hydrochloride once daily on days 1-42 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 33 of patients experience dose-limiting toxicity Once the MTD is determined patients are treated with erlotinib hydrochloride at the MTD and sunitinib malate
Patients undergo blood and tumor specimen collection periodically during study for future correlative studies
PROJECTED ACCRUAL A total of 49 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 |
|---|---|---|---|
| OHSU-SOL-06051-LM | OTHER | OHSU Knight Cancer Institute | httpsreporternihgovquickSearchP30CA069533 |
| P30CA069533 | NIH | None | None |
| OHSU-2683 | OTHER | None | None |