Urologic Oncology Trials

Choosing to participate in a clinical trial is an important personal decision.  Carefully conducted clinical trials are the fastest and safest way to find whether new drugs or treatments are both safe and effective.  Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.  All clinical trials have guidelines about who can participate.  Researchers use protocols with defined criteria to identify appropriate participants and maintain safety stanards.  For commonly asked questions about clinical trials, see www.clinicaltrials.gov.

UNC Urologic Oncology currently has clinical trials available to qualifying patients.

Current Urologic Oncology Trials

Prostate Cancer

Cornell 001 Phase I Docetaxel + Anti-PMSA MAB in Castrate Resistant Prostate Cancer

07-658 - Lifestyles in White and African American prostate cancer survivors

08-1049 - High Intensity Focused Ultrasound (HIFU) in low risk prostate cancer

ACCP002-0-Cyber knife for low and intermediate risk prostate cancer

ZD 4054-15 - ZD 4054 vs placebo in Hormone Refractory prostate cancer, non-metastatic

Upcoming:

•  BC1-06Alpharadin Ph GIII hormone refractory prostate cancer with bone metastases, no visceral metastases
• G300213 Toremifine

Bladder Cancer

14CL403 - A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.

LCCC 0521 - Muscle Invasive Bladder - Neo-adjuvant Erlotinib (Tarceva®), followed by radical cystectomy; 3 months post-operative restart of Tarceva for up to 2 years.

Upcoming:

Renal Cell Cancer

A6181109 Adjuvant Sutent vs Placebo in RCC with high risk of recurrence

Lilly-JZAI - LY573636-sodium with Sunitinib (Sutent) in metastatic RCC - first line treatment

Upcoming:

• In development - neo-adjuvant Pazopanib in RCC (bx, 8 wks of tx, followed by nephrectomy)
  
• CRAD2202 - Phase II comparison study of RAD001 (everolimus) then Sutent vs Sutent then everolimus

Phase I Advanced Solid Tumors with No Standard Therapy Options

NC10863 Pazopanib in patients with advanced malignancies and liver dysfunction

C14001 - MLN8237 novel aurora a kinase inhibitor

LCCC0621 - Combination of everolimus, 5-FU/LV, Folfox6, Folfox/Panitumumab

CLCL161A2101 - Oral LCL161 in advanced solid tumors (except bladder)

20070411 - A Phase Ib/2 open label, dose escalation study of AMG 655 in combination with AMG 479 (except prostate)

For more information on the above studies please contact Gayle Grigson at 919-966-4432 or pager number 919-216-9466 or Patricia Robinson at 919-966-4432 or pager 919-216-0571.