Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma

10:04 EST 3rd March 2015 | BioPortfolio


The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride (Tarcevaâ„¢) and sirolimus (Rapamuneâ„¢) in the treatment of patients with metastatic kidney cancer.


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 (Tarcevaâ„¢) and sirolimus (Rapamuneâ„¢). This is a single arm trial with no placebo or drug-based control arm

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Renal Cell Carcinoma


Erlotinib hydrochloride, Sirolimus


University of Colorado Hospital
United States




University of Colorado, Denver

Results (where available)

View Results


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