Phase II Safety and Efficacy Study of Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Metastatic or Unresectable Sarcomatoid Renal Cell Carcinoma
Gemcitabine and capecitabine are designed to disrupt the growth of cancer cells, which may
cause cancer cells to start to die. Bevacizumab is a drug that binds to and inhibits
Vascular Endothelial Growth Factor (VEGF), a blood-vessel stimulating agent with unusually
high levels in kidney cancer.
If you are found to be eligible to take part in this study, you will receive gemcitabine,
capecitabine, and bevacizumab on a 28 day cycle. Capecitabine will be taken by mouth (with
food), twice daily, on Days 1-21. Gemcitabine will be given through a needle in your vein
in your arm over 30 minutes on Days 1 and 15. Bevacizumab will be given through a needle in
your vein in your arm on Days 1 and 15. It will be given over 120 minutes for Cycle 1 and
over 60 minutes for all other cycles. Your doctor may decided to give you bevacizumab over
30 minutes if you tolerate the treatment well.
On the first day of each cycle, blood (about 2 teaspoons) and a urine will be collected
before treatment for routine tests. You will also have blood drawn on Day 15 (about 2
teaspoons) for routine tests.
Every 8 weeks, you will have a CT scan of your chest, abdomen, and pelvis and a chest x-ray.
You will be asked about any drugs that you are currently taking and you will have a
complete physical exam. You will be asked about any side effects that you might have
experienced since the last visit and your ability to perform daily activities will be
evaluated. Repeat bone scans and MRI of the brain may be done if your doctor thinks it is
You will continue receiving treatment for a maximum of 12 months. However, if you are
benefitting from treatment, you may be able to continue receiving it off study. You will be
taken off study if the disease gets worse, if the side effects are intolerable, or if you
develop another illness that prevents you from receiving the treatment.
This is an investigational study. Gemcitabine, capecitabine, and bevacizumab are all FDA
approved and commercially available. Up to 40 participants may take part in this study.
All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Event Free Survival
Evaluation of response will follow the Response Evaluation Criteria in Solid Tumors (RECIST).
Baseline and with each 4 week cycle or until disease progression
Lance Pagliaro, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|