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

LCCC 0420 - High Risk - initial treatment with triple concurrent therapy - hormone therapy for 2 years; with 8 weeks concurrent weekly Docetaxel (Taxotere®) and external beam radiotherapy.

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

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

02-0767 - Decision making under uncertainty in prostate cancer

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

Upcoming:

• 002-00 Randomized - bicalutaminde with and without deforolimus in asymptomatic, castrate-resistant prostate cancer
• ZD 4054-15 - Hormone refractory prostate cancer, non-metastatic
• ZD 4054-33 - Hormone refractory prostate cancer, metastatic

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.

EFC 6668 - Locally advanced/metastatic urothelial or bladder cancer:  First line treatment with either LAROTAXEL + Cisplatin (LC) versus Gemcitabine + Cisplatin (GC)

Upcoming:

• ZD6474 - Bladder cancer randomized Docetazel +/- ZD 6474
• 14CL403 - Alvimopan (Entereg) for management of postoperative ileus in cystectomy patients

Renal Cell Cancer

CHIC001- Evaluating FDG-PET as a predictive marker for mTOR directed therapy with RAD 001 Everolimus in metastatic renal cell cancer refractory to kinase treatment

Upcoming:

• JZAI - LY573636 sodium with Sunitinib (Sutent) in metastatic renal cell carcinoma - first line treatment

Phase I Advanced Solid Tumors with No Standard Therapy Options

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)

LCCC0613 - Sorafenib with cisplatin/etoposide or carboplatin/pemetrexed (except bladder)

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