Clinical Trial: Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Everolimus Versus Sunitinib Therapy in Patients With Advanced Non-clear Cell Renal Cell Carcinoma

Brief Summary: The goal of this clinical research study is to compare the effectiveness of Afinitor (everolimus) and Sutent (sunitinib) for the treatment of advanced renal cell carcinoma (kidney cancer). The safety of each treatment will also be studied.

Detailed Summary:

The Study Drugs:

Everolimus is designed to stop cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.

Sunitinib is designed to block pathways that control important events (such as the growth of blood vessels) that are essential for the growth of cancer.

Study Groups and Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups.

  • If you are assigned to Group 1, you will take 2 everolimus tablets by mouth once every day.
  • If you are assigned to Group 2, you will take sunitinib capsules by mouth every day for 4 weeks, followed by 2 weeks off.

If you have any side effects from any of the drugs, tell the study doctor right away. The study doctor may then lower the dose or keep the dose level the same.

Every 6 weeks on this study is called a study "cycle."

If the disease gets worse or you have intolerable side effects while you are on study, you will have the chance to receive the study drug that you did not receive at first. The dosing and follow-up will be the same as for all participants in that group.

Study Visits:

On Day 1 of every cycle:

  • You will have a physical exam, including measurem
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: Progression-Free Survival (PFS) [ Time Frame: Beginning of every 6 week cycle from baseline to disease progression or intolerable side effects. ]

    Time to event endpoints descriptively summarized by Kaplan-Meier curves. Evaluation of response follows the Response Evaluation Criteria in Solid Tumors.


    Original Primary Outcome: Progression-Free Survival (PFS) [ Time Frame: Beginning of every 6 week cycle from baseline to disease progression or intolerable side effects. ]

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: August 18, 2010
    Date Started: August 2010
    Date Completion:
    Last Updated: January 5, 2017
    Last Verified: January 2017