Clinical Trials
Genitourinary Protocols (bladder, kidney, prostate...)
1. E3805: Chemohormonal Therapy vs. Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer1.
The purpose of this study is to evaluate a new way of treating patients with prostate cancer. One group will receive docetaxel chemotherapy both at the time you are starting hormonal therapy and later when/if the hormonal therapy is no longer working per your doctor decision. Another group of study patients only get chemotherapy when/if the hormonal therapy is no longer working per your doctor decision. We are doing the study to see if there is a benefit to giving chemotherapy at the beginning.
2. 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.
3. CALGB 90802: Randomized Phase III Trial Comparing Everolimus + Placebo vs. Everolimus + Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors
The purpose of this study is to compare the effects of a drug called everolimus alone with those of the combination of everolimus and a drug called bevacizumab for advanced kidney cancer to find out which is better. In this study, you will get either the combination of everolimus and a placebo or the combination of everolimus and bevacizumab.
4. 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.
5. RTOG 0831: PEDS: A Randomized Double Blinded, Placebo-Controlled Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated with Radiotherapy for Prostate Cancer
The purpose of this study is to compare the effects, good and/or bad, of a drug, tadalafil, with a placebo (an inactive drug). Tadalafil is given as a treatment for erectile dysfunction (inability to maintain an erection long enough to engage in sexual intercourse). This study is being done to find out if tadalafil prevents erectile dysfunction in men with prostate cancer who are undergoing radiation therapy (that is, if the drug helps the participants taking it to maintain an erection following sexual stimulation). In this study, you will get tadalafil or placebo. You will not get both.
6. 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).
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.