Genitourinary Protocols (bladder, kidney, prostate...)
As of July 8, 2013 - protocols do open and close daily.
Please check with your physician for additional protocols and/or information.
1. CALGB 90601: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, & Bevacizumab to Gemcitabine, Cisplatin, & Placebo in Patients with Advanced Transitional Cell Carcinoma
The purpose of this study is to compare the effects, good and/or bad, of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on you and your transitional cell cancer to find out which is better.
2. S0931: EVEREST: Everolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
The purpose of this study is to see whether treatment with everolimus after surgery for kidney cancer will increase the time without cancer returning. The current standard treatment after surgery is careful monitoring with no immediate treatment. Studies suggest that one way kidney cancer may grow is through chemical signaling through a protein named “mTOR”. Everolimus is a drug that stops signaling through mTOR and may therefore stop the growth of kidney cancer. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for use after surgery. In this study, you will get either everolimus or placebo (a pill with no medication). You will not get both.
3. S1014: Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation
The purpose of this study is to find out what effects, good and/or bad, abiraterone acetate has on you and your prostate cancer. The effect of the prostate cancer will be measured by a blood test (prostatic specific antigen or PSA).
4. S1107: Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell Carcinoma
The purpose of this study is to find out what effects, good and/or bad, there are to treating papillary kidney cancer with an investigational agent ARQ 197 or a combination of ARQ 197 with erlotinib. Erlotinib is an investigational drug that has been approved by the FDA for the treatment of lung cancer. The combination of these two drugs is also investigational.
Papillary kidney cancer is a rare type of kidney cancer that does not respond well to medications currently approved for kidney cancer treatment. Lab research indicates that the protein/enzyme called MET plays an important role in the growth and spread of papillary kidney cancer. The experimental drug ARQ 197 blocks the function of the MET protein/enzyme and it is hoped that it will shrink or slow down the growth of papillary kidney cancer. Another protein that has been found to play a role in growth of papillary kidney cancer is EGFR. Erlotinib is a medication that blocks EGFR function. Lab studies suggest that the combination of ARQ 197 and erlotinib may slow down the growth of papillary kidney cancer better than ARQ 197 alone.
5. S1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental.
TAK-700 is a pill that works by reducing the levels of testosterone and other male hormones that help your prostate cancer grow. TAK-700 acts on the adrenal glands and inside the prostate tumors and slows the amount of male hormones being produced. By lowering the amount of male hormones in your body, TAK-700 is expected to control the growth of your prostate cancer
6. E2810: Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Subjects with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastasectomy
The purpose of this study is to determine whether taking an oral drug known as pazopanib (Votrient®) will reduce the risk of the cancer recurring in the future.
Pazopanib is approved by the FDA for patients who have metastatic renal cell carcinoma. However, it has not been tested in patients who have had all visible areas of their cancer removed surgically, and is considered experimental in this situation. We don’t know if pazopanib will be helpful to patients in this scenario. There is currently no standard of care for patients in this situation but careful observation without treatment is considered reasonable.
For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133.