Clinical Trials – Genitourinary (Renal, Prostate & Bladder)

Clinical Trials – Genitourinary (Renal, Prostate & Bladder)

Clinical Trials – Genitourinary (Renal, Prostate & Bladder)

GU PROTOCOLS: Bladder/Urinary Tract
1. CALGB 90601
Progressive, Metastatic or Locally Advanced Transitional Cell ca of the Urinary Tract
Eligibility: T4b, N2, N3 or M1 disease of bladder, ureter, renal pelvis, prostate or urethra; prior (neo)adj chemo okay if >/= 1 year to progression; no prior systemic combination chemo for metastatic dz; no prior angiogenesis inhibitors; no known brain mets; no CHF: Rx: Gencitabine/Cisplatin x 6 cycles (max) + Bevacizumab/placebo until dz progression. (BEVACIZUMAB/PLACEBO SUPPLIED)

1. CALGB 90802
Previously Treated Advanced Renal Cell Carcinoma
Eligibility: stage IV renal cell cancer with clear cell component; progressive dz after Rx with at least 1 VEGFR TKI therapy; no prior VEGF binding agent or mTOR inhibitor; no active brain mets; performance status 0-2: RX: Everolimus 10mg po qd plus Bevacizumab or placebo 10 mg/kg IV q 2 wks.

2. SWOG 0931
Intermediate or Very High Risk Renal Cell Carcinoma
Eligibility: Clear cell or non-clear cell allowed (collecting duct or medullary carcinomas excluded); requires full surgical resection (radical or partial nephrectomy incl. removal of all clinically pos lymph nodes); negative margins; bilateral renal tumors eligible; no residual or distant mets; no prior anti-cancer therapy (except surgery); Performance status: 0,1. RX: Everolimus 10 mg daily x 54 weeks versus Placebo (EVEROLIMUS/PLACEBO PROVIDED)

GU PROTOCOLS: Prostate Radiation (RTOG)
1. RTOG 0232
Prostate Cancer
Histologically confirmed adenocarcinoma stage T1c – T2b. Gleason 7 if PSA < 10 or Gleason < 7 if PSA 10-20. Zubrod 0-1. No prior chemo or pelvic RT. No previous hormonal tx beginning < 2 mos or > 6 mos prior to rando. Arm 1: Radiation + Permanent Brachytherapy Arm 2: Brachytherapy alone.

2. RTOG 0534
Rising PSA after Radical Prostatectomy
Eligibility: lymph node negative adenoCa of the prostate treated by prostatectomy; post surgical PSA of >/= 0.2 – < 2.0; pathologic T3N0/Nx dz or T2N0/Nx dz if surgical margin positive or prostatic fossa or urethral-vesical anastomosis biopsies are positive; PSA doubling time > 6 mos prior to registration: RX: Prostate bed RT (PBRT) versus PBRT + neoadjuvant and concurrent short term androgen deprivation (NC-STAD) versus Pelvic lymph node RT + PBRT + NC-STAD. (NO DRUG SUPPLIED)

3. RTOG 0831
Prevention of Erectile Dysfunction
Eligibility: Clinical stage T1b-T2b adenocarcinoma of prostate; clinically neg lymph nodes; no bone mets; Planned external RT alone OR brachytherapy (combined Rx are excluded); RT to pelvic and/or para-aortic LN’s are not allowed; Perf status 0 or 1; No use of LHRH agonist androgen suppression w/in last 6 mos. Rx: Tadalafil 5 mg x 24 wks versus Placebo. (TADALAFIL/PLACEBO PROVIDED)

CALGB = Cancer and Leukemia Group B
CTSU = Cancer Trials Support Unit
ECOG = Eastern Cooperative Oncology Group
NCI = National Cancer Institute
NSABP = National Surgical Adjunct Breast and Bowel Project
RTOG = Radiation Therapy Oncology Group
SCUSF = SunCoast CCOP Research Base
SWOG = Southwest Oncology Group
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