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Clinical Trials

Clinical trials are strictly controlled studies of new and emerging therapies. At MD Anderson, these trials incorporate state-of-the-art of patient care, while carefully evaluating how best to apply the most recent developments in cancer medicine.

We have clinical trials for every stage bladder cancer. Some are appropriate for newly diagnosed patients who have not undergone treatment. Others involve patients who have already received specific types of treatment, or whose treatment may have failed.

Bladder cancer trials are conducted in MD Anderson's Genitourinary Care Center.

Neoadjuvant chemotherapy

High risk (i.e., locally advanced)

A Phase II Clinical Trial of Neoadjuvant Chemotherapy with M-VAC Plus Avastin in Patients with Locally Advanced Urothelial Cancer: Our research found that cancers which over-express VEGF (Vascular Endothelial Growth Factor) have a higher rate of relapse despite pre-operative chemotherapy. Avastin is an anti-angiogenic drug which blocks blood vessel growth by binding to VEGF. This clinical trial involves aggressive chemotherapy given before surgical removal of the bladder in patients with a low chance of cure by means of surgery only. This trial is also available for patients with certain sub-types of bladder cancer that are known to be more aggressive.
Principal Investigator:Arlene O. Siefker-Radtke, M.D.
Protocol Number:2006-0620

Metastatic urothelial cancer

Phase I Two-Dimensional Dose-Finding Study of Bortezomib in Combination with Gemcitabine/Doxorubicin in Metastatic Surgically Unresectable Urothelial Cancer or Other Solid Tumors: Bladder cancer is a chemo-sensitive tumor with response rates on the order of 50-70% with front-line treatments. Unfortunately, when patients relapse, their tumors are less likely to respond as their cancer cells become more resistant to chemotherapy. Pre-clinical studies suggest that the proteosome inhibitor bortezomib can enhance the sensitivity of cancer cells to agents such as gemcitabine and doxorubicin and overcome this resistance. This trial is available for patients with metastatic urothelial cancer who have failed prior chemotherapy.
Principal Investigator:Arlene O. Siefker-Radtke, M.D.
Protocol Number:2006-0014

Phase II Trial of Weekly Docetaxel (Taxotere) versus Weekly Docetaxel in Combination with ZD1839 (Iressa® ) as Consolidation Therapy for Metastatic Urothelial Cancer Following Maximal Response to Multi-Agent Chemotherapy: Many patients who initially respond to chemotherapy are at a high risk of relapse. Research from our Bladder SPORE suggests that agents such as docetaxel and iressa may delay cancer progression. This trial is available for patients with metastatic urothelial cancer who have responded to initial chemotherapy, and who wish to continue with milder low-dose chemotherapy as a means of trying to delay progression of their cancer.
Principal Investigator:Arlene O. Siefker-Radtke, M.D.
Protocol Number:2003-0767

Rare bladder tumors

Phase II Trial of 5-Fluorouracil, Leucovorin, Gemcitabine and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant:This trial is only available at MD Anderson. It is for patients with a rare variant of bladder cancer. 
Principal Investigator: Arlene Siefker-Radtke, M.D.
Protocol Number: ID03-0111

Phase 1B Intravesical Administration of SCH 721015 in Patients with Transitional Cell Carcinoma of the Bladder: This protocol seeks to determine the safety and tolerability of two instillations of intravesical SCH 721015 in admixture with the novel excipient SCH 209702 (Syn3).
Principal Investigator: Colin Dinney, M.D.
Protocol Number: 2009-0938

A Phase II, Randomized, Open Label, Parallel Arm Study to Evaluate the Safety and Efficacy of rAd-IFN/Syn3 Following Intravesical Administration in Subjects with High Grade, BCG Refractory, or Relapsed Non-Muscle Invasive Bladder Cancer (NMIBC): This protocol seeks to evaluate the incidence of high-grade-recurrence-free survival at 12 months and to determine the time to progression to muscle-invasive disease.
Principal Investigator:   Ashish Kamat
Protocol Number: 2012-0609

Non-muscle invasive (“superficial”) bladder cancer

Markers of Response to Intravesical Bladder Cancer Therapy: This trial is designed for patients who are undergoing treatment with intravesical BCG (with or without interferon). Patients who are receiving such therapy will undergo various urinary and serum based tests. These tests are aimed to help us to develop a ‘risk profile’ to identify those patients who will fail therapy prior to actual manifestation of tumor. Such surrogate markers of response to intravesical immunotherapy would enable clinicians to offer tailored therapy to patients with bladder cancer, thus optimizing the timing of curative treatments for this disease. Of particular importance is our desire to make the study “user (i.e., patient and physician) friendly.” Therefore, the study has been designed to allow the intravesical therapy to be administered in the office of the referring physician. Only specific assays will need be performed at MD Anderson Cancer Center.
Principal Investigator: Ashish M. Kamat, M.D.
Protocol Number: LAB05-0326


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