Genitourinary Trials

Renal (Kidney)

CALGB 90601                  Principal Investigator: Larry Schlabach, MD

                                                           Co-Investigator: John McCravey, MD and Matt Graham, MD

Title:  A Randomized Double-blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab (IND #7921, NSC #704865) to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma (IRB#: 12-084)

NCT #: NCT00942331        Phase: Phase III

Purpose:  This randomized phase III trial is studying gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, cisplatin, and placebo in treating patients with advanced urinary tract cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether gemcitabine hydrochloride and cisplatin are more effective when given together with or without bevacizumab in treating patients with urinary tract cancer.

Drugs possibly given:
Bevacizumab                                                                                                                                                                                                                                                                                   Cisplatin                                                                                                                                                                                                                                                                                                         Gemcitabine hydrochloride                                                                                                                                                                                                                                                                        Placebo                  

Please view complete information about this trial at: http://www.clinicaltrials.gov/ct2/show/NCT00942331?term=90601&rank=1

E2810                           Principal Investigator: Larry Schlabach, MD

                                           Co-Investigator: John McCravey, MD and Matt Graham, MD

Title:  Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients With Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastasectomy (IRB#: 12-075)

NCT #: NCT01575548        Phase: Phase III

Purpose:  This phase III trial studies how well pazopanib hydrochloride works compared to placebo in treating patients with metastatic kidney cancer who have no evidence of disease after surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Drugs possibly given:
Pazopanib
Placebo

 Please view complete information about this trial at: http://clinicaltrials.gov/ct2/show/NCT01575548?term=E2810&rank=1

S0931                               Principal Investigator: Larry Schlabach, MD

                                                Co-Investigator: John McCravey, MD and Matt Graham, MD 

Title: EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy (IRB#: 11-071)

NCT #: NCT01120249        Phase: Phase III

Purpose:  This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

Drugs possibly given:
Everolimus
Placebo

Please view complete information about this trial at: http://www.clinicaltrial.gov/ct2/show/NCT01120249?term=S0931&rank=1

Prostate

 RTOG 0924                   Principal Investigator: Larry Schlabach, MD

                                                Co-Investigator: John McCravey, MD and Matt Graham, M.D.

Title: A Phase III Randomized Trial of Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer. (IRB#: 11-120)

NCT #: NCT01368588       Phase: Phase III

Purpose: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

Drugs possibly given:
Radiation therapy
Selective external radiation therapy
 

Please view complete information about this trial at: http://www.clinicaltrial.gov/ct2/show/NCT01368588?term=RTOG0924&rank=1

S1216                                 Principal Investigator: Larry Schlabach, MD

                                                Co-Investigator: John McCravey, MD and Matt Graham, MD

Title: 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 (IRB#: 13-014)

NCT #: NCT01809691       Phase: Phase III

Purpose: The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.

Drugs possibly given:
TAK-700
Bicalutamide
 

Please view complete information about this trial at: http://www.clinicaltrials.gov/ct2/show/NCT01809691?term=S1216&rank=1