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Interior Cancer Journal

Ongoing Clinical Trials

Prospective international observational cohort non-comparative study describing the safety and effectiveness of ZALTRAP® administered in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer in current clinical practice: A Post-Authorisation Safety Study (PASS)

This multicenter observational study is investigating the long-term safety and clinical outcomes of ZALTRAP in combination with FOLFIRI as a standard-of-care treatment. Approximately 1,000 adults with metastatic colorectal cancer who have failed treatment with an oxaliplatin-based regimen will be enrolled at sites across the country, with 24 to be enrolled at the Houston site.

Lead Physician:Julie Rowe, M.D.
Contact: Christine Marie Kent, 832.325.6515, Christine.M.Kent@uth.tmc.edu

A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate nab-Paclitaxel (Abraxane) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC) 

Researchers are evaluating the use of Abraxane® (nab-paclitaxel) as a maintenance treatment in non-small cell lung cancer (NSCLC) patients, after response or stable disease with nab-paclitaxel plus carboplatin, in the areas of safety, efficacy and progression-free survival. The study will enroll about 540 male and female adults with stage IIIB or IV squamous cell NSCLC, with 6 to be enrolled at the Houston study site.

Lead Physician:Syed Jafri, M.D.
Contact: Christine Marie Kent, 832.325.6515, Christine.M.Kent@uth.tmc.edu

A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

This Phase 2B/3 trial will determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide plus adjuvant temozolomide prolongs progression-free survival (PFS) and overall survival time (OS) among subjects with newly diagnosed glioblastoma multiforme (GBM) harboring EGFR amplification. 

Lead Physician: Sigmund Hsu, M.D.
Contact: Guangrong Lu (Greg), 713.704.7100, Guangrong.Lu@uth.tmc.edu

A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy versus Physician’s Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations

In this multicenter trial, investigators are determining the efficacy of olaparib versus physician’s choice single-agent chemotherapy (weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine) in subjects with relapsed ovarian cancer. Efficacy is measured by assessment of progression-free survival (PFS) using blinded independent central review (BICR). Adult females with relapsed ovarian cancer possessing the BRCA1 or BRCA2 mutation and have received at least 2 prior platinum-based chemo regimens are eligible to take part. Overall, 411 subjects from 100 sites in 15 countries will be enrolled.

Lead Physician: Joseph A. Lucci III, M.D.
Contact: Dr. Sonia Robazetti, 713.500.6382, Sonia.C.Robazetti@uth.tmc.edu

A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer: The TRANSFORMER Trial (Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance)

Investigators are determining whether treatment with higher doses of testosterone will improve radiographic progression-free survival compared to enzalutamide in men with metastatic castrate-resistant prostate cancer (CRPC) post-treatment with abiraterone. This site will enroll 10 asymptomatic men with metastatic CRPC with no disease-related symptoms who have been treated with continuous ADT and have progressed after treatment with abiraterone. All subjects will be screened for insurance that covers enzalutamide in case they are randomized to that treatment arm.

Lead Physician: Robert J. Amato, M.D.
Contact: Christine Marie Kent, 832.325.6515, Christine.M.Kent@uth.tmc.edu

A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

In this Phase 3 placebo-controlled, randomized study, researchers are determining the efficacy and tolerability of veliparib in combination with carboplatin and paclitaxel as continuation maintenance therapy in subjects with untreated Stage III or IV high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer. This site will enroll 20 women (ages 18 and older) who have had no prior systemic therapy.

Lead Physician:Elizabeth Nugent, M.D.
Contact: Dr. Sonia Robazetti, 713.500.6382, Sonia.C.Robazetti@uth.tmc.edu

Evaluation of Safety and Efficacy of Electrochemotherapy in the Treatment of Pancreatic Adenocarcinoma  

Investigators are assessing the safety and maximally tolerated electroporation field strengths in combination with chemotherapy (gemcitabine and nab-paclitaxel) treatments for patients with locally advanced unresectable pancreatic adenocarcinoma, and to examine and describe treatment changes of the tumor and surrounding stroma. Twenty-four male and female adults (ages 18 years and older) with Stage II or III pancreatic adenocarcinoma that is locally advanced or borderline resectable will be enrolled at this site.

Lead Physician: Derek West, M.D.
Contact: Karen Parker Swaby, 713.704.2842, Karen.P.Swaby@uth.tmc.edu