Cancer Treatment Trials by Disease Site

Feist-Weiller Cancer Center Current Treatment Studies

Clinical Research Office

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Cancer treatment trials are studies that evaluate whether new developments in cancer treatment are safe, more effective, and better than those currently available. These trials are designed to compare investigational (new) therapies with standard therapy regimens. Investigational therapies include new cancer drugs, new combinations of drugs already in use, new methods for surgical resection and radiation therapy, alternative therapies, and new methods for cancer prevention, screening, or diagnosis. Studies are also being done to help improve a patient's quality of life during and after treatment.

Clinical trials have greatly increased our understanding of the factors that contribute to the development and growth of tumors. This is turn has led to new methods of treatment. Analysis of the data from the large number of participants involved in clinic trials may take years, but the accuracy and reliability of the data thus obtained provide real answers about the safety and efficacy of new treatments.

Interested participants are being screened for studies in the following disease sites. Click name for easy navigation:

Breast Cancer Studies	Lung Cancer Studies
Brain Cancer Studies	Leukemia Studies
Gastrointestinal Cancer Studies	Lymphoma Studies
Genitourinary Cancer Studies	Sickle Cell Disease Studies
Gynecologic Cancer Studies	Cancer Control Trials
Head & Neck Cancer Studies

STUDY	PRINCIPAL INVESTIGATOR	CONTACT
BREAST CANCER STUDIES
PACCT-1: Trial Assigning Individualized Options for Treatment: the TAILORx Trial (adjuvant) Criteria: Newly diagnosed Adenocarcinoma of the female breast;ER/PR+, node negative, HER2 negative; no prior chemo IRB#H07-37; IRB Approval Date 9/25/06	Glenn Mills, MD	Janice Yager Phone: 318.813.1403 Email: jyager@lsuhsc.edu
B-39: 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 Criteria: Newly diagnosed Stage 0 (DCIS), I or 2 adenocarcinoma of breast; tumor ≤3cm; lumpectomy with negative margins IRB#H08-27 IRB Approval Date: 8/14/07	Glenn Mills, MD	Janice Yager Phone: 318.813.1403 Email: jyager@lsuhsc.edu
Pfizer A6181099: A randomized phase III study of Sunitinib in combination with Capecitabine compared with Capecitabine in patients with previously treated breast cancer Criteria: Metastatic adenocarcinoma of the breast; HER2 positive or negative; ≤2 prior metastatic treatments IRB#H07-100-IRB Approval Date: 3/26/07	Gary Burton, MD	Janice Yager Phone: 318.813.1403 Email: jyager@lsuhsc.edu
CTSU/I24-02: A phase III trial evaluating the role of ovarian function suppression and the role of exemestane as adjuvant therapies for premenopausal women with endocrine responsive breast cancer Criteria: Newly diagnosed adenocarcinoma of the breast; premenopausal, ER and/or PR+ patients; current adjuvant chemo ok IRB#H04-065;IRB Approval Date:10/27/03	Glenn Mills, MD	Janice Yager Phone: 318.813.1403 Email: jyager@lsuhsc.edu
INVESTIGATOR STUDY: A Phase II Trial of Vinorelbine in Combination with Bevacizumab in First-Line Treatment of Her2-neu Negative Metastatic Breast Cancer Criteria: Newly diagnosed visceral, HER2-neu negative metastatic breast cancer; no prior treatment for metastatic disease IRB #H09-144; IRB Approval Date: 6/3/09	Dolly Quispe, MD	Kristen Katz Phone: 318.813.1400 Email: tkatz@lsuhsc.edu
SWOG S0226: Phase III randomized trial of Anastrozole versus Anastrozole and Fulvestrant as first line therapy for post menopausal women with metastatic breast cancer Criteria: Metastatic adenocarcinoma of the breast; Postmenopausal ER and/or PR+ patients; No prior treatment for metastatic disease IRB #H06-051	Glenn Mills, MD	Janice Yager Phone: 318.813.1403 Email: jyager@lsuhsc.edu
*BRAIN CANCER STUDIES*		Back to Top
CTSU/RTOG 0825: Phase III double-blind placebo controlled trila of conventional concurrent chemoradiation and adjuvant temozolomide plus bevacizuman vs. conventional concurrent chemoradiation and adjuvant temozolomide in patients with newly diagnosed glioblastoma. Criteria: Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV); Karnofsky performance status ≥ 70; No prior tx for brain or head/neck cancers; No prior temozolomide or bevacizumab, or glidial wafer therapy IRB #H10-25; IRB Approval Date: 10/07/09	Glenn Mills, MD	Martha Lennard 318-813-1410 Email: mlenna@lsuhsc.edu
*GASTROINTESTINAL CANCER STUDIES*		Back to Top
CTSU C-80405: A phase III trial of Irinotecan/5 FU/Leucovorin or Oxiplatin/5-FU/Leucovorin with bevacizumab, or Cituximab (C225), or with the combination of Bevacizumab and Cetuximab for patients with untreated metastatic adencarcinoma of the COLON or RECTUM Criteria: Metastatic or locally advanced adenocarcinoma of the colon or rectum; No prior treatment for metastatic disease IRB#H07-021;IRB Approval Date: 08/28/06	Glenn Mills, MD	Wendy Pruitt Phone: 318.813.1484 Email: wpruit@lsuhsc.edu
CTSU/NSABP R-04: A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with Preoperative Radiation Therapy and Continuous Intravenous Infusion of (CVI) of 5-Fluorouracil (5-FU) in the Treatment of Patients with Operable Carcinoma of the RECTUM Criteria: Stage II or III newly diagnosed adenocarcinoma of the rectum amenable to curative surgery IRB#H06-038;IRB Approval Date: 09/26/05	Glenn Mills, MD	Wendy Pruitt Phone: 318.813.1484 Email: wpruit@lsuhsc.edu
CTSU/E5202: A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin vs. 5-FU, Leucovorin, Oxaliplatin & Bevacizuman in Paitnets with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers Criteria: Newly diagnosed, completely resected, stage II, adenocarcinoma of the colon; node positive IRB#H09-096;IRB Approval Date: 02/04/09	Glenn Mills, MD	Wendy Pruitt Phone: 318.813.1484 Email: wpruit@lsuhsc.edu
THRESHOLD TRIAL – TH-CR-402: TH-302: in Combination with Gemcitabine in the Treatment of Advanced Pancreatic Cancer Criteria: Locally advanced, unresectable or metastatic adenocarcinoma of the pancreas; No prior treatment for pancreatic cancer except radiosensitizing 5-FU IRB#10-055 ;IRB Approval Date: 11/11/09	Shantan Reddy, MD	Wendy Pruitt Phone: 318.813.1484 Email: wpruit@lsuhsc.edu
SWOG 0727: Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First Line Treatment in Patients with Metastatic Pancreatic Cance Criteria: Stage IV, unresectable adenocarcinoma of the pancreas; No prior treatment for advanced or locally advanced pancreatic cancer. IRB#H10-023 ;IRB Approval Date: 10/7/09	Glenn Mills, MD	Wendy Pruitt Phone: 318.813.1484 Email: wpruit@lsuhsc.edu
CTSU/ROTG 0436: A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for patients with Esophageal cancer who are treated without surgery. Criteria: T1N1M0; T2-4, Any N, M0; or Any T, Any N, M1; Must be treated with Chemo/XRT only PS = Zubrod 0-2 IRB#H10-041 ;IRB Approval Date: 10/7/09	Glenn Mills, MD	Wendy Pruitt Phone: 318.813.1484 Email: wpruit@lsuhsc.edu
ACOSOG Z4051 - A Phase II Study of Neoadjuvant Therapy with Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients with Locally Advanced Adenocarcinoma of the Distal Esophagus Criteria: Histologic proof of resectable primary adenocarcinoma of the distal esophagus or GE junction, Siewert Type I or II. TNM stages T3NOMOm T2-3N1, M0, or T2-3N0-1M1a IRB#H10-074 ;IRB Approval Date: 02/03/10	Quyen Chu, MD	Wendy Pruitt Phone: 318.813.1484 Email: wpruit@lsuhsc.edu
*GENITOURINARY CANCER STUDIES*		Back to Top
CALGB 90202: Phase III: Randomized, double-blind, placebo-controlled study of early vs. standard zoledronic acid to prevent skeletal related events in men with PROSTATE cancer metastatic to bone Criteria: Newly diagnosed advanced prostate cancer; must have at least one bone metastasis; MUST be on androgen deprivation therapy IRB#H07-019;IRB Approval Date: 08/28/06	Donald Elmajian, MD	Ryan Wilkerson Phone: 318.675.5655 Email: rwilke@lsuhsc.edu
C-90203: Randomized phase III study of neo-adjuvant docetaxel and androgen deprivation prior to radical protstatectomy versus immediate radical prostatectomy in patients with high-risk, clinically localized PROSTATE cancer Criteria: Newly diagnosed, Hi-risk localized prostate cancer IRB#H08-067;IRB Approval Date: 11/26/07	Donald Elmajian, MD	Ryan Wilkerson Phone: 318.675.5655 Email: rwilke@lsuhsc.edu
S0421: Phase III study of docetaxel and atrasentan versus docetaxel and placebo for patients with advanced hormone refractory PROSTATE cancer Criteria: Advanced prostate cancer; must have bone metastases; No prior chemo for metastatic disease IRB#H08-026;IRB Approval Date: 08/27/07	Donald Elmajian, MD	Ryan Wilkerson Phone: 318.675.5655 Email: rwilke@lsuhsc.edu
SWOG S0337: A phase III blinded study of immediate post-TURBT instillation of gemcitabine versus saline in patients with newly diagnosed or occasionally recurring grade I/II superficial BLADDER cancer Criteria: Newly diagnosed or recurrent grade 1-2, Ta-T1, transitional cell carcinoma of the bladder IRB#H08-049;IRB Approval Date: 10/29/07	Donald Elmajian, MD	Ryan Wilkerson Phone: 318.675.5655 Email: rwilke@lsuhsc.edu
E2805: A randomized, double-blind, phase III trial of adjuvant sunitinib versus sorafenib versus placebo in patients with resected RENAL cell carcinoma (H07-071) Criteria: Newly diagnosed intact renal cell carcinoma that is eligible for nephrectomy with curative intent IRB#H07-071;IRB Approval Date: 12/18/06	Donald Elmajian, MD	Ryan Wilkerson Phone: 318.675.5655 Email: rwilke@lsuhsc.edu
THRESHOLD TRIAL – TH-CR-402: TH-302: in Combination with Taxotere in the Treatment of Advanced or Castrate Resistant Prostate Cancer Criteria: Metastatic Adenocarcinoma of the prostate, or disease that has progressed while on hormone therapy & primary androgen-abalation therapy given. No prior treatment for advanced disease. IRB#10-055 ;IRB Approval Date: 11/11/09	Shantan Reddy, MD	Ryan Wilkerson Phone: 318.675.5655 Email: rwilke@lsuhsc.edu
*GYNECOLOGIC CANCER STUDY*		Back to Top
No study available at this time
*HEAD & NECK CANCER STUDIES*		Back to Top
E1305: A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer Criteria: Recurrent, incurable by surgery or XRT, or metastatic squamous cell carcinoma of the head/neck; no prior tx. for advanced disease; no nasopharyngeal cancer WHO types 2 or 3 IRB#H10-063 ;IRB Approval Date:01/06/10	Glenn Mills, MD	Georgia Morgan Phone: 318.813.1498 Email:gmorg4@lsuhsc.edu
A Survey of Biomarker in Head and Neck Cancers IRB#H96-417; Approval Date - 1/26/96	Dr. Cherie-Ann Nathan	Cheryl Clark, PhD 318.675.6259 or pager 318.675.7007 #2101 Email: cdixon@lsuhsc.edu
Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy other than Surgical Resection Alone for Newly Diagnosed Head and Neck Carcinoma IRB #H06-109; Approval Date: 4/24/06	Dr. Cherie-Ann Nathan	Cheryl Clark, PhD 318.675.6259 or pager 318.675.7007 #2101 Email: cdixon@lsuhsc.edu
Prospective Trial on Return of Vocal Cord Mobility Predicting Response to Radiation +/- Chemotherapy IRB #H08-072; Approval Date: 12/19/07	Dr. Cherie-Ann Nathan	Cheryl Clark, PhD 318.675.6259 or pager 318.675.7007 #2101 Email: cdixon@lsuhsc.edu
An exploratory Biomarker Trial of the Food Substances Curcumin C3 Complex® with or without Bioperine® in Subjects with Newly Diagnosed or Recurrent Head and Neck Squamous Cell Carcinoma IRB #H08-181; Approval Date: 11/26/07	Dr. Cherie-Ann Nathan	Cheryl Clark, PhD 318.675.6259 or pager 318.675.7007 #2101 Email: cdixon@lsuhsc.edu
Prospective Study on Reflux in Heak and Neck Patients IRB #H08-180; Approval Date: 7/28/08	Dr. Cherie-Ann Nathan	Cheryl Clark, PhD 318.675.6259 or pager 318.675.7007 #2101 Email: cdixon@lsuhsc.edu
The Role of PET Scans in Head and Neck Cancer IRB #H09-053; Approval Date: 3/5/09	Dr. Cherie-Ann Nathan	Cheryl Clark, PhD 318.675.6259 or pager 318.675.7007 #2101 Email: cdixon@lsuhsc.edu
*LUNG CANCER STUDIES*		Back to Top
S0819: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizu-mab with or without Concurrent Cetuximab in Patients Advanced Non-Small Cell Lung Cancer (NSCLC) Criteria: Newly diagnosed Stage IV Non-small cell lung cancer; no prior treatment IRB#H010-011;IRB Approval Date: 09/09	Glenn Mills, MD	Cindy Diaczynski Phone: 318.813.1406 Email:cdiacz@lsuhsc.edu
THRESHOLD TRIAL – TH-CR-402: TH-302: in Combination with Docetaxel in the Treatment of Advanced Non-Small Cell Lung Cancer (Second-line treatment) Criteria: Stage IIIB or IV Non-small cell lung cancer; must have progression after one prior treatment for advanced NSCLC IRB#10-055 ;IRB Approval Date: 11/11/09	Shantan Reddy, MD	Cindy Diaczynski Phone: 318.813.1406 Email:cdiacz@lsuhsc.edu
THRESHOLD TRIAL – TH-CR-402: TH-302: in Combination with Pemetrexed in the Treatment of Advanced Non-Small Cell Lung Cancer Criteria: Stage IIIB or IV Non-small cell lung cancer (non-squamous cell); must have progression after one prior treatment for advanced NSCLC IRB#10-055 ;IRB Approval Date: 11/11/09	Shantan Reddy, MD	Cindy Diaczynski Phone: 318.813.1406 Email:cdiacz@lsuhsc.edu
H06-128: Phase I/II Study of Polyphenon E in addition to Erlotinib in advanced non-small cell lung cancer Criteria: Stage IV, non-small cell lung cancer; may have had ≥2 prior treatments for metastatic disease IRB#H06-128;IRB Approval Date: 05/26/06	Glenn Mills, MD	Kristen Katz Phone: 318.813.1400 Email: tkatz@lsuhsc.edu
*LEUKEMIA STUDIES*		Back to Top
Antisoma Study: Phase 3, Open-Label, Randomized Study of Amonafide L-Malate in Combination with Cytarabine, Compared to Daunorubicin in Combination with Cytarabine in Patients with Secondary Acute Myeloid Leukemia (AML) (Protocol 0001A3-300-GL) Criteria: Newly diagnosed secondary AML; secondary to prior exposure to leukemogenic agent, or from transformation of MDS or CMML IRB#H09-122;IRB Approval Date: 05/06/09	Francesco Turturro, MD	Lori Panu Phone: 318.813.1405 Email:lpanu@lsuhsc.edu
CTSU/C10603 - A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) or Placebo in Newly Diagnosed Patients < 60 years of age with FLT3 Mutated Acute Myeloid Leukemia (AML) Criteria: Newly diagnosed AML with FLT3 mutation; No prior chemo; Patients must be <60 years of age IRB#H010-010;IRB Approval Date: 09/09	Glenn Mills, MD	Cindy Diaczynsky Phone: 318.813.1406 Email:cdiacz@lsuhsc.edu
SWOG 0805: Phase II Study of Combination of Hyper-CVAD and Dasatinib with or without Allogeneic Stem Cell transplant in Patients with Philadelphia (Ph) Chromosome Positive and/or Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) Criteria: Patients with morphologically diagnosed ALL with evidence of ALL involvement in bone marrow and/or blood; one prior course of remission induction therapy for ALL is allowed. Patients must have rapidly progressive disease. IRB#10-062 ;IRB Approval Date: 12/15/09	Glenn Mills, MD	Cindy Diaczynsky Phone: 318.813.1406 Email:cdiacz@lsuhsc.edu
Wyeth H08-006: Phase 1/2 study of SKI-606 in Philadelphia chromosome positive leukemias Criteria: Patients with any phase of Ph+ CML or AML who are resistant to or intolerant of treatment with Gleevec IRB#H08-006;IRB Approval Date: 07/30/07	Jonathan Glass, MD	Lori Panu Phone: 318.813.1405 Email:lpanu@lsuhsc.edu
Novartis CAMN107AUS09: A multicenter, open-label, exploratory study of BCR-ABL Kinetics Criteria: Adult patients on Nilotinib with Philadelphia chromosome positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a suboptimal molecular response to Imatinib IRB#H09-002;IRB Approval Date: 07/28/08	Jonathan Glass, MD	Lori Panu Phone: 318.813.1405 Email:lpanu@lsuhsc.edu
*LYMPHOMA STUDIES*		Back to Top
SWOG 0816: A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma using Interim FDG-PET Imaging Criteria: New diagnosed, Stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich or lymphocyte depleted). Pts must be age 18-60, inclusive IRB#H10-059 ;IRB Approval Date: 12/2/09	Francesco Turturro, MD	Cindy Diaczynsky Phone: 318.813.1406 Email:cdiacz@lsuhsc.edu
SWOG S0350: Phase II trail of CISPLATIN plus ETOPOSIDE plus GEMCITABINE plus SOLUMEDROL (PEGS) in peripheral t-cell non-Hodgkin’s lymphoma (H08-085) Criteria: Newly diagnosed Peripheral T-cell NHL, nodal or extra-nodal; Stages III, IV, Bulky stage II; no prior treatment IRB #H08-085; Approval Date: 12/17/07	Glenn Mills, MD	Cindy Diaczynsky Phone: 318.813.1406 Email:cdiacz@lsuhsc.edu
Cephalon: An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab Compared with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in the First-Line Treatment of Patients With Advanced, Indolent Non-Hodgkin’s Lymphoma(NHL) or Mantle Cell Lymphoma Criteria: Newly diagnosed CD20+ B-Cell NHL including follicular lymphoma, Waldenstrom’s macro-globulinemia, splenic marginal zone B-cell lymphoma MALT lymphoma, nodal marginal zone B-cell lymphoma, or Mantle cell lymphoma IRB#H10-011 ;IRB Approval Date: 10/7/09	Francesco Turturro, MD	Kristen Katz Phone: 318.813.1400 Email: tkatz@lsuhsc.edu
*SICKLE CELL DISEASE*		Back to Top
HemaQuest Pharmaceuticals: HQP 2008-004: A Randomized, Double-blind, Placebo-controlled, dose Escalation Study to Evaluate the Safety, tolerability and Pharmacokinetics of HQK-1001 in Subjects with Sickle Cell Disease. Criteria: Patients ages 12-45 diagnosed with sickle cell disease or sickle beta thalassemia; must have had at least one episode of a SCD-related crisis or complication per year for an average or 3 yrs., or one acute chest syndrome over the prior 5 yrs. IRB#H010-001;IRB Approval Date 08/05/09	Jonathan Glass, MD	Lori Panu Phone: 318.813.1405 Email:lpanu@lsuhsc.edu
*CANCER CONTROL TRIALS*		Back to Top
CCCWF 97106: A randomized study to determine whether Arginmax improves the sexual function and quality of life in female cancer patients Criteria: All disease sites; minority female patients only, with concern of sexual dysfunction after chemo; completed chemo. ≥6 mo. prior to enrollment & be disease free for 3 months IRB#H08-041;IRB Approval Date: 09/24/07	Glenn Mills, MD	Georgia Morgan Phone: 318.813.1498 Email:gmorg4@lsuhsc.edu
S0715- “Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) For the Prevention of Taxane Induced Neuropathy, Phase III.” Criteria: Breast cancer patients receiving a taxane-based chemotherapy regimen IRB#H10-024 ;IRB Approval Date: 9/16/09	Glenn Mills, MD	Georgia Morgan Phone: 318.813.1498 Email:gmorg4@lsuhsc.edu
MDA 2006-0841 Randomized, Double-blind, Placebo-controlled Trial of Palonosetron and Dexamethasone with or without Dronabinol for the Prevention of Chemotherapy-induced Nausea and Vomiting after Moderately Emetogenic Chemotherapy Criteria: Chemo-naïve Patients receiving moderately emetogenic chemotherapy with IV Cytoxan and/or adriamycin IRB#H09-063 ;IRB Approval Date: 11/5/08	Glenn Mills, MD	Georgia Morgan Phone: 318.813.1498 Email:gmorg4@lsuhsc.edu