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A Study of Temsirolimus and Sorafenib as Second-Line Therapy in Patients with Advanced Renal Cell Carcinoma that Has Grown Despite First-Line Sunitinib Therapy

[Protocol 07-124]

Full Title :
A RANDOMIZED TRIAL OF TEMSIROLIMUS VS. SORAFENIB AS SECOND-LINE THERAPY IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA WHO HAVE FAILED FIRST-LINE SUNITINIB THERAPY
Purpose :

Sunitinib (Sutent®) is a drug approved for treating renal cell carcinoma. This study is evaluating the drugs temsirolimus and sorafenib in patients with advanced renal cell carcinoma that has continued to grow despite initial treatment with sunitinib.

Sorefanib (Nexavar®) is already approved for the treatment of renal cell carcinoma. It works by stopping a signal made by cancer cells, which they need to multiply and grow, and through inhibiting blood supply to cancer cells. Temsirolimus is an investigational drug that works by inhibiting mTOR, an important regulatory protein in a key signaling pathway that governs cancer cell growth and division.

Patients will be randomly assigned to receive either temsirolimus or sorafenib (not both). Researchers will determine if each drug can control cancer growth and/or prolong the lives of patients with metastatic renal cell carcinoma.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of metastatic renal cell carcinoma that has progressed despite first-line therapy with sunitinib.
  • At least 2 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Robert Motzer at 646-422-4312.

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