Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma
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
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
University of Colorado, Denver
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00353301
- ClinicalTrials.gov processed this data on November 12, 2013
RATIONALE: Erlotinib and sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects a...
This randomized phase II trial studies how well tivantinib with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot ...
The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to dete...
Primary objective: To determine the 6-month progression free survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus. Secondary objectives: To further ...
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and dasatinib when given together with erlotinib hydrochloride in treating patients with pancreatic c...
Chromophobe renal cell carcinoma is a distinct subtype of renal cell carcinoma that accounts for 5% of all renal tumors. This subtype is further subdivided into two variants, classic and eosinophilic,...
Renal cell carcinoma, a common malignant tumor arising from the kidney, occurs in 3.62 and 1.95 cases per one hundred thousand people among men and women, respectively, in Taiwan each year. Approximat...
OBJECTIVE:To investigate the expression of apolipoprotein A-I(ApoA-I) in eight histological types of renal neoplasms and to explore a new biomarker for differential diagnosis.METHODS: The immunochemis...
Sarcomatoid renal cell carcinoma is a tumour with aggressive behaviour. It is a form of dedifferentiated carcinoma with high incidence of metastases to the lungs. We report a case of 55-year-old male ...
Cystic renal cell carcinoma (CRCC) is relatively rare; CRCC is frequently misdiagnosed as a benign renal cyst. CRCC carries an excellent prognosis following surgical treatment. The aim of our study wa...
Medical and Biotech [MESH] Definitions
A heterogeneous group of sporadic or hereditary carcinoma derived from cells of the KIDNEYS. There are several subtypes including the clear cells, the papillary, the chromophobe, the collecting duct, the spindle cells (sarcomatoid), or mixed cell-type carcinoma.
An autosomal dominant disorder caused by mutations in a tumor suppressor gene. This syndrome is characterized by abnormal growth of small blood vessels leading to a host of neoplasms. They include HEMANGIOBLASTOMA in the RETINA; CEREBELLUM; and SPINAL CORD; PHEOCHROMOCYTOMA; pancreatic tumors; and renal cell carcinoma (see CARCINOMA, RENAL CELL). Common clinical signs include HYPERTENSION and neurological dysfunctions.
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
A rare tumor of the female genital tract, most often the ovary, formerly considered to be derived from mesonephric rests. Two varieties are recognized: (1) clear cell carcinoma, so called because of its histologic resemblance to renal cell carcinoma, and now considered to be of muellerian duct derivation and (2) an embryonal tumor (called also ENDODERMAL SINUS TUMOR and yolk sac tumor), occurring chiefly in children. The latter variety may also arise in the testis. (Dorland, 27th ed)
A carcinoma arising from MERKEL CELLS located in the basal layer of the epidermis and occurring most commonly as a primary neuroendocrine carcinoma of the skin. Merkel cells are tactile cells of neuroectodermal origin and histologically show neurosecretory granules. The skin of the head and neck are a common site of Merkel cell carcinoma, occurring generally in elderly patients. (Holland et al., Cancer Medicine, 3d ed, p1245)