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To determine the recommended dosage of Sunitinib and Dalteparin in patients with metastatic renal cell cancer. To evaluate the safety and tolerability of combination of Sunitinib and Dalteparin.
This research study is being done to see if the addition of Dalteparin to the standard treatment (Sunitinib) slows vascular tumors like renal cell carcinoma by stopping vessel growth. Dalteparin is an anticoagulant used against blood clots but also has been shown to stop blood vessel growth. Dalteparin has been shown to increase the survival of patients with cancer. Sunitinib blocks the activation of multiple growth factor receptors involved in vessel and tumor growth. Sunitinib is the common name for the commercial drug Sutent. Sunitinib is the standard of care for patients with advanced kidney cancer, but is not curative. Dalteparin and Sunitinib are approved by the Food and Drug Administration (FDA) and are commercially available. However, the combination of these drugs Dalteparin and Sunitinib has not been tested in humans. Thus, the effects of these drugs in combination, good and bad, and the correct dose of the drugs to give are not known.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Renal Cell Carcinoma
Sunitinib and Dalteparin mono and combination therapy
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Published on BioPortfolio: 2014-08-27T03:16:13-0400
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This is a multi-national, phase II, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell carcinoma...
Targeted therapy with the tyrosine kinase inhibitor sunitinib is used in the first line of metastatic renal cell carcinoma (mRCC) treatment. The aim of the present study was independent validation of ...
The aim was to investigate the relationships between total sunitinib plasma concentrations (sunitinib plus its active metabolite; N-desethyl sunitinib) and clinical outcomes in Japanese patients with ...
Adjuvant sunitinib therapy compared with placebo prolonged disease-free survival (DFS) in patients with locoregional high-risk renal cell carcinoma in the S-TRAC trial (ClinicalTrials.gov number, NCT0...
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Relative dose intensity is an indicator of therapeutic efficacy in sunitinib treatment for metastatic renal cell carcinoma. However, the number of studies investigating the influence of decreased rela...
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.
Therapy with two or more separate preparations given for a combined effect.
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)
Renal Cell Carcinoma
Renal cell cancer (renal adenocarcinoma or hypernephroma) is the most common type of kidney cancer in adults. More than 8 in every 10 (80%) kidney cancers diagnosed in the UK are this type. In renal cell cancer the cancerous cells start in the lini...
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...
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