Study on Pre-Surgery Use of Sutent for Kidney Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT00715442

Provider View

This clinical trial is exploring whether taking the drug Sutent (sunitinib malate) before surgery can help manage kidney cancer. The study will also look at the safety of this treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if taking Sutent (sunitinib malate) before surgery can help control kidney cancer. Sutent works by blocking pathways that help cancer grow, especially by stopping the growth of blood vessels that feed the tumor. The study will also assess how safe this treatment is for patients.

Description

Study Drug:

Sutent (sunitinib malate) is a medication designed to block pathways that help cancer grow, particularly by stopping the growth of blood vessels that tumors need.

Study Treatment:

If you qualify for this study, you will take Sutent once a day for 4 weeks, followed by a 2-week break. This 6-week period is one cycle of treatment. During the second cycle, you will have surgery to remove the tumor. After surgery, you will start taking Sutent again on the same schedule.

Study Visits:

At the start of each cycle (Cycles 1-6), you will have:

  • A review of your medical history
  • A physical exam, including vital signs and weight
  • An evaluation of your activity level
  • Questions about any medications you're taking and any side effects
  • Blood tests to check your health and thyroid function
  • Scans to check the status of your cancer
  • An ECG to check your heart health

Every 2 cycles, you may have additional heart tests if needed.

Starting in Cycle 7, you will visit the clinic every other cycle (about every 12 weeks) unless your doctor advises more frequent visits. At each visit, you will have similar tests as before.

Length of Study:

You will continue taking Sutent unless your cancer worsens, you experience severe side effects, or you need a different treatment.

Early Withdrawal:

If you leave the study early, you will have similar tests as during regular visits.

Post Treatment Evaluation:

About 30 days after your last dose of Sutent, you will return for a follow-up visit with similar tests.

Long-Term Follow-Up:

After treatment, you will be contacted regularly to check on your health every 6-12 weeks for the first 2 years, and every 6 months for up to 5 years.

This study is investigational, and while Sutent is FDA approved for kidney cancer, its use with surgery is for research purposes. Up to 50 patients will participate, all at MD Anderson.

Eligibility Criteria

Inclusion Criteria

  • Have confirmed metastatic clear cell kidney cancer and are eligible for surgery to remove the kidney.
  • Have measurable disease that can be accurately measured by scans.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have adequate organ and bone marrow function based on specific blood test results.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.
  • Agree to use medically acceptable birth control methods during the study.
  • Provide written informed consent to participate.

Exclusion Criteria

  • Have had an organ transplant.
  • Have had major surgery or significant injury recently.
  • Have another type of cancer, except for certain skin cancers or other cancers treated and disease-free for 2 years.
  • Have received prior treatment for kidney cancer, except for radiation therapy more than 2 weeks ago.
  • Are scheduled to receive another experimental drug during the study.
  • Have a primary brain tumor or brain metastases.
  • Have serious heart conditions or uncontrolled high blood pressure.
  • Have other serious diseases or conditions that could affect the study.
  • Are receiving other systemic therapy for kidney cancer.
  • Require total parenteral nutrition.
  • Have a history of bleeding disorders or recent thrombosis.
  • Have a serious, non-healing wound or fracture.
  • Are pregnant or breastfeeding.
  • Have a history of abdominal issues like fistula or perforation recently.
  • Have a known allergy to Sutent.

Locations

FACILITYZIPCITYSTATE
Baylor College of Medicine77030HoustonTexas
University of Texas MD Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.