Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353301
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2006-07-14
Brief Title:
Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Phase II Single Arm Clinical Trial to Evaluate the Efficacy and Safety of the Combination of Tarceva Erlotinib Hydrochloride and Rapamune Sirolimus in the Treatment of Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-03
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:
The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride Tarceva and sirolimus Rapamune in the treatment of patients with metastatic kidney cancer
Detailed Description:
Despite recent advances metastatic renal cell carcinoma remains an incurable condition Currently available treatment with high-dose interleukin-2 can lead to complete responses in a small minority of selected patients but is markedly toxic and not broadly available FDA-approved multikinase inhibitors sorafenib and sunitinib malate often cause partial and transient tumor regression There is no standard treatment metastatic renal cell carcinoma for patients whose disease progressed on multikinase inhibitors The kinase mammalian target of rapamycin mTOR is overstimulated in a subset of renal cell carcinomas and other malignancies and can be blocked by sirolimus leading to growth arrest Erlotinib hydrochloride is a drug that blocks the function of the epidermal growth factor receptor EGFR often over expressed in kidney cancer Sirolimus and EGFR inhibitors and been safely used in combination In vitro experiments show that erlotinib enhances the sirolimus induced growth impairment in a panel of renal cell carcinoma cells In the present study patients with metastatic renal cell carcinoma whose disease progressed on multikinase inhibitors will be treated with the combination of erlotinib hydrochloride Tarceva and sirolimus Rapamune This is a single arm trial with no placebo or drug-based control arm
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