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Ellis Fischel Cancer Center and MD Anderson

Clinical Trials

Clinical trials are research studies that involve people. They are the final step in a long process that begins with research in a lab and animal testing.  Many treatments used today are the result of past clinical trials.

Ellis Fischel Cancer Center physicians and staff ensure that all of our patients receive the best care. This means if we ask you or a loved one to participate in a clinical trial, we have good reason to believe that the new treatment(s) will help and we see promise and potential in the new treatment options. These new treatments could become the new standard of care and we want only the best for our patients. 

Why Have Clinical Trials?

In cancer, clinical trials are designed to answer questions about new ways to:

  • Treat Cancer
  • Find and diagnose cancer
  • Prevent cancer
  • Manage symptoms of cancer or side effects from its treatment

Studies are designed to answer questions about new treatments or ways of using an existing treatment better.  These trials test many types of treatments, such as new:

  • Drugs or vaccines
  • Ways to do surgery or give radiation therapy
  • Combinations of treatments

Please visit the following link for more information from the National Cancer Institute (NCI) about Clinical Trials:  http://www.cancer.gov/clinicaltrials/learningabout

Brain Cancer Clinical Trials

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma 

Breast Cancer Clinical Trials

Adjuvant

  • A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low  Invasive Breast Cancer
  • A Phase III, Randomized Clinial Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in AW/MF Patinets with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or less.
  • A Randomized Phase III Clinical Trial Evaluating Post- Mastectomy Chestwall and Regional Nodal XRT and Post-Lucmpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who convert to Pathologically Negative Axillary Nodes after Neoadjuvant ChemotherapyA Phase III Trial of Accelerated Whole Breast Irradiation With Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer  
  • A Phase III Trial of Accelerated Whole Breast Irradiation With Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer
  • Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, hormone Receptor-Positive and HERS/neu Negative Breast Cancer.

Ductal Carcinoma In Situ

  • A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
  • Phase II Study of Neoadjuvant Letrozole for  Postmenopausal Women with Estrogen Receptor Positive Ductal Carcinoma Situ (DCIS)                                                                             


Neo Adjuvant

  • A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens with Weekly Paclitaxel and Neratinib or Trastuzumab Followed by Doxorubicin and Cyclophosphamide with Postoperative Trastuzumab in Women with Locally Advanced HER2-Positive Breast Cancer
  • Alternate approaches for clinical stage II or III Estogen Receptor Positive breast cancer NeoAdjuvant Treatment (ALTERNATE) In Postmenopausal women: A Phase III Study                    


Metastatic

  • A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

Gastrointestinal (GI) Cancer Clinical Trials

Colon

  • A Phase III Open-Label, Randomized, Multicenter Study of Imprime PGG in Combination with Cetuximab in subjects with Recurrent or Progressive KRAS Wild Type Colorectal Cancer
  • Phase III Randomized Study of Adjuvant FOLFOX Chemotherapy Comprising Oxaliplatin, Leucovorin Calcium, and Fluorouracil With Versus Without Celecoxib in Patients With Resected Stage III Colon Cancer


Liver 

  • Phase III Randomized Study of  Sorafenib Plus Doxorubicin Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)

Pancreatic

  • Phase III Randomized Study of Adjuvant Gemcitabine Hydrochloride With Versus Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With Versus Without Chemoradiotherapy With Either Capecitabine or Fluorouracil in Patients With Resected Head of Pancreas Adenocarcinoma **Temporarily Closed**
  • Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 ( NSC-749607)  vs Mfolfox  in Patients with Metastatic Pancreatic Cancer After Prior Chemotherapy                                          

Rectal

  • A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer PatientsUndergoing Low Anterior Resection with Total Mesorectal Excision

Genitourinary Cancer Clinical Trials

Prostate

  • Phase III Trial of Dose Excalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GNRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GNRH Agonist and TAK-700 for Men With High Risk Prostate Cancer
  • A Phase III Randomized Trail Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer                                           
  • Phase III of Enzalutamide (NSC# 766085) Versus Enzalutamide Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer                                   
  • Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

Renal

  • A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab To Gemcitabine, Cisplatin, and Placebo in Patients With Advanced Transitional Cell Carcinoma   
  • Prospective  Randomized Phase II Trial of Pazopanib (NSC# 737754, IND # 75648 Versus Placebo in Patients With Progressive Carcinoid Tumors                                                             

Gynecological Cancer Clinical Trials

Cervical

  • Phase III Randomized Study of Adjuvant Radiation Versus Chemoradiation Therapy in Patients With Intermediate-Risk Stage I-IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy

Endometrial

  • Phase III Randomized Study of Adjuvant Chemoradiotherapy Comprising Cisplatin and Tumor Volume-Directed Radiotherapy Followed by Carboplatin and Paclitaxel Versus Carboplatin and Paclitaxel Alone in Patients With Stage I-IVA Endometrial Carcinoma

Miscellaneous

  • Phase III Randomized Study of Adjuvant Chemotherapy Comprising Carboplatin and  Paclitaxel With Versus Without Bevacizumab and/or Secondary Cytoreduction Surgery in Patients With Platinum-Sensitive Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

Head and Neck Cancer Clinical Trials

Locally Advanced

  • Phase III Randomized Study of Adjuvant Intensity-Modulated Radiotherapy With Versus Without Cetuximab in Patients With Locally Advanced Resected Squamous Cell Carcinoma of the Head and Neck

Metastatic

  • Phase III Randomized Study of Platinum-Containing Chemotherapy With Versus Without Bevacizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

    Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel And Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck

Lung Cancer Clinical Trials

Non-Small Cell Lung Cancer

  • Randomized phase III Study of Maintance Therapy With Bevacizumab, Pemetrexed, or a Combination Of Bevacizumab and Premetrexed, Following Carboplatin Paclitaxel and Bevacizumab for Advanced Non-Squamous


Limited-Stage Small Cell Lung Cancer

  • Phase III Randomized Study of Three Different Thoracic Radiotherapy Regimens in Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Skin Cancer Clinical Trials

Melanoma

  • A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA 4 Therapy Versus High-Dose Interferon α-2b for stage IIIB – IV Resected High-Risk Melanoma **Arm A accrual closed**

  • A Randomized Phase II Trial of Carboplatin, Paclitaxel, Bevacizumab, with or without Everolimus for Therapy of Metastatic Malignant Melanoma

Hematology Clinical Trials

Leukemia

  • Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine: Daunorubicin) Liposome Injection Versus Cytarabine And Daunorubicin in Patients 60-75 Years of age with untreated High Risk (Secondary) AML                     

  • A Randomized Phase III Study of Standard Cytarabin Plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytaragine (IA) versus IA with Vorinostat (NSC-701852) (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)    

  • Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid) Alone and in Combination with Epoetin Alfa (Procrit) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia 

  • A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

  • A  Randomized Phase III Study of Bendamustie Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/=65 Years Of age) with Chronic Lymphocytic Leukemia          

Lymphoma

  • A Randomized Phase II Trial of Ofatumumab and Bendamustine vs. Ofatumumab, Bortezomib (NSC #681239, IND #58443) and Bendamustine in Patients with Untreated Follicular Lymphoma

  • Intergroup Randomized Phase II Four Arm Study In Patients Greater Than or Equal to 60 With Previously Untreated Mantle Cell Lymphoma

  • Phase II Study of Dose-Ajusted EPOCH +/- Rituximab in Adults with untreated Burkitt Lymphoma, C-Myc positive Diffuse large B Cell Lymphoma and Plasmablastic Lymphoma **Accural is on hold for now***