Adult Clinical Trials

Breast Cancer Trials

IRB# 6823: S0307: "Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer"

IRB# 6781: BP-59: Bone Marrow Analysis in Early-Stage Breast Cancer

IRB# 6700: ECOG; PACCT-1: Program for the Assessment of Clinical Cancer Tests (PACCT-1) Trial Assigning Individualized Options for Treatment

IRB# 6057: S0226: Phase III Randomized Trial of Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women with Metastic Breast Cancer

IRB# 5899: S0221: Phase III Trial of Continuous Schedule AC + G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node Positive or High-Risk Node-Negative Breast Cancer

IRB# 6389: NSABP B-39/RTOG 0413: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer

IRB# 6733: CALGB 40302: Endocrine Therapy with or without inhibition of EGF and HER2 Growth Factor Receptors: A randomized, double blind placebo-controlled phase III trial of fulvestrant with or without Lapatinib (GW572016) for postmenopausal women with hormone receptor positive advanced breast cancer

IRB# 5636: CALGB 40101: Cyclophosphamide and Doxorubicin (CA)(4 vs. 6 cycles) vs. Paclitaxel (4 vs. 6 cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A 2X2 Factorial Phase III Randomized Study

B-36: A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC) in Patients With Node-Negative Breast Cancer
Contact Varney Rannells, RN at 504-568-4747

B42: NSABP B-42: A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer
Contact Varney Rannells, RN at 504-568-4747

Gastrointestinal Trials (GI)

IRB# 6541; E5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

IRB# 6705: N0147 Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/ Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

IRB# 6736: CALGB/SWOG C80405: A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the combination of Bevacizumab and Cetuximab for Patients with untreated Metastatic Adenocarcinoma of the colon or rectum

An Open-label, Phase II Study Evaluating the Safety and Efficacy of CPTK787/ZK222584 in Patients with Metastatic Neuroendocrine Tumors That Have Evidence of Progressive Disease or an Increase in Disease Related Syndrome Symptoms
Contact Julie Nunez, RN at 504-895-5748

An Open Label, Stratified, Single Arm Phase II Study of RAD001 in Patients Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy
Contact Julie Nunez, RN at 504-895-5748

Genitourinary Trials (GU)

IRB# 6806: S0354: A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients with Hormone Refractory Prostate Cancer.

IRB# 6867: E2805: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

IRB# 5788: R0232; Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy with Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma

IRB# 2973: S9346; Intermittent Androgen Deprivation in Subjects with Stage D2 Prostate Cancer, Phase III

Gynecology Trials

IRB# 6479: GOG 0209: A Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel/G-CSF Versus Carboplatin/Paclitaxel in Patients with Stage III & IV or Recurrent Endometrial Cancer

Head and Neck Cancer Trials

IRB# 6035: CCCWFU #60A02: A Phase II Randomized Placebo-Controlled, Double-blinded Trial to Evaluate the Effects of Fruit and Vegetable Extracts on Intermediate Biomarkers in Head and Neck Cancer Patients

Leukemia Trials

IRB# 6125: S0106: A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mulotarg) Induction Therapy Versus Standard Induction with Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy with Gemtuzumab Ozogamicin (Mylotarg) or No Additional Therapy for Patients Under Age 56 with Previously Untreated De Novo Acute Myeloid Leukemia (AML)

Lymphoma Trials

IRB# 3761: S9704: A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose Chop Chemotherapy for Patients with Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate and High Risk International Classification Prognostic Groups

IRB# 6142: E4402: Randomized, Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Low Tumor Burden Patients with Indolent Non-Hodgkin's Lymphoma

Miscellaneous

Use of High Dose Radioactive (125-I, 131-I) Iodine-Labeled Somatostatin Analogs for the Treatment of Subjects with Somatostatin Receptor-Positive Tumors
Contact Varney Rannells, RN at 504-568-4747

Pilot Trial to Determine the Feasibility of a One Step Sentinel Lymph Node Biopsy Procedure Using Radiolabeled Methylene Blue (IND 70,627)
Contact Varney Rannells, RN at 504-568-4747