Clinical Trials: For Patients and Family
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Cancer Treatment Trials
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.
Current therapeutic clinical trials at Feist-Weiller Cancer Center
BREAST STUDIES
PACCT-1: Trial Assigning Individualized Options for Treatment: the TAILORx Trial (adjuvant)
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
Pfizer A6181099 (H07-100): A randomized phase III study of Sunitinib in combination with Capecitabine compared with Capecitabine in patients with previously treated breast cancer
Pfizer A6181077 (H07-046): A randomized phase II study of SUO11248 versus standard of care for patients with previously treated, advanced, triple receptor negative (ER, PER and HER2) breast cancer
Pfizer A6181064 (H07-080): A randomized, phase III study of Docetaxel in combination with Sunitinib versus Docetaxel in the first line treatment of advanced breast cancer
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 (H004-065)
CTSU E5103: A double blind phase III trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or placebo in patients with lymph node positive and high risk lymph node negative breast cancer (H08-084)
SWOG S0221: Phase III trial of continuous schedule of AC+G vs Q2 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 (H04-149)
ECOG E1105: A randomized Phase III double-blind placebo controlled trial of first-line chemotherapy and Trastuzumab with or without Bevacizumab for patients with HER-2/NEU over-expressing metastatic breast cancer (H08-108)
SWOG S0226: Phase III randomized trial of Anastrozole versus Anastrozole and Fulvestrant as first line therapy for post menopausal women with metastatic breast cancer (H06-051)
HEAD AND NECK STUDIES
Amgen 20062088 (H08-069): Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy in Patients with Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
RTOG R0522: A randomized phase III trial of concurrent accelerated radiation and CISPLATIN versus concurrent accelerated radiation, CISPLATIN, and CETUXIMAB (C225) [followed by surgery for selected patients] for stage III and IV head and neck carcinomas (H08-025)
CCCWF 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 (H08-052)
GASTROINTESTINAL STUDIES
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 (H07-021)
CTSU N0147 - N0147: A randomized phase III trial of Oxiplatin (Oxal) plus 5-FU/ Leucovorin (CF) with or without Cetuximab after curative resection for patients with stage III COLON cancer (H08-021)
CTSU/NSABP R-04 - 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 (H06-038)
LUNG STUDIES
S0533: A pilot trial of cisplatin/etoposide/radiotherapy followed by consolidation docetaxel and the addition of bevacizamub (NSC-704865) in three cohorts of patients with inoperable locally advanced stage IIIA/IIIB non-small cell lung cancer
Novartis H07-063: A two-step phase I study investigating the combination of RAD001 with carboplatin, paclitaxel and bevacizamub in stage IIIB/IV NSCLC patients not treated previously with systemic therapy
Genentech H07-106: A placebo-controlled, double-blind, multicenter, randomized, phase II study of bevacizamub in previously untreated extenisve-stage small cell lung cancer (AVF3995g)
H06-128: Phase I/II Study of Polyphenon E in addition to Erlotinib in advanced non-small cell lung cancer.
GENITOURINARY STUDIES
ECGC Green Tea: Green tea extract and prostate cancer: non-randomized single-arm phase II stuidy of polyphenon E qd for approximately 6 weeks (between PROSTATE biopsy and radical prostatectomy)(neoadjuvant)
S9346: Phase II: intermittent androgen deprivation in patients with stage D2 PROSTATE cancer (casodex and zoladex)
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
Amgen 103/H06-115: Randomized, double-blind, multicenter study of denosumab compared with Zometa in the treatment of bone metastases in men with hormone-refractory PROSTATE cancer
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 (H08-67)
S0421: Phase III study of docetaxel and atrasentan versus docetaxel and placebo for patients with advanced hormone refractory PROSTATE cancer (H08-026)
SWOG S0353: Phase II study of intravesical gemcitabine in patients with recurrent superficial transitional cell carcinoma of the BLADDER that has failed prior intravesical bacillus calmette-guerin (H07-131)
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 (H08-049)
Wilex: Phase III: a randomized double blind study to evaluate adjuvant cG250 treatment vs. placebo in patients with clear cell RCC and high risk of recurrence (H05-017)
E2805: A randomized, double-blind, phase III trial of adjuvant sunitinib versus sorafenib versus placebo in patients with resected RENAL cell carcinoma (H07-071)
SWOG S0337: A phase III blinded study of immediate post-turbt instillation of Gemcitabine versue saline in patients with newly diagnosed or occasionally recurring grade I/II superficial BLADDER cancer (H08-049)
CTSU 90203: A randomized phase III study of neo-adjuvant Docetaxel and Androgen deprivation prior to radical prostatectomy versus immediate radical prostatectomy in patients with high-risk, clinically localized PROSTATE cancer (H08-067)
CTSU 90202: A randomized, double-blind, placebo-controlled phase III study of early versus standard Zoledronic Acid to prevent skeletal related events in men with PROSTATE cancer metastatic to bone (H07-019)
SWOG S0437 - S0437: Prostate Cancer Prevention Trial (PCPT) Companion Long Term Follow Up Study for Men Diagnosed with PROSTATE Cancer (H06-099)
LEUKEMIA STUDIES
Genzyme H06-107: A phase III randomized, double-blind, controlled study comparing clofarabine and cytarabine versus cytarabine alone in adult patients 55 years and older with acute myelogenous leukemia (AML) who have relapsed or are refractory after receiving up to two prior induction regimes
S0106: A phase III study of the addition of gemtuzumab ozogamicin (Mylotarg®) during 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
Biogen Idec H07-098: A randomized, open-label, multicenter, phase II study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide, and rituximab versus fludarabine, cyclophsophamide, and rituximab alone in subjects with relapsed chronic lymphocytic leukemia
Wyeth H08-006: Phase 1/2 study of SKI-606 in Philadelphia chromosome positive leukemias
IRB #H08-096: A phase 1/2, multi-center, open-label study of the safety and efficacy of a stepwise dose-escalation schedule of Lenalidomide monotherapy in subjects with relapsed or refractory B-cell chronic lymphocytic leukemia (Celgene Protocol CC-5013-CLL-001)
Novartis CAMN107A2303 (H08-054): A phase III multi-center, open-label, randomized study of IMATINIB versus NILOTINIB in adult patients with newly diagnosed Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Sunesis SPO-0014 (H08-148) A Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of SNS-595 Injection in Patients Greater than or Equal to 60 Years of Age with Previously Untreated Acute Myeloid Leukemia.
LYMPHOMA STUDIES
Biogen Idec H07-079): Phase III, open-label, prospective, two-armed, multicenter, randomized, group sequential study to evaluate the efficacy and safety of subsequent treatment with the Zevalin (ibritumomab tiuxetan) study regimen versus observation in patients with diffuse large B-cell lymphoma who are in complete remission after first-line CHOP-rituximab (CHOP-R) therapy
S0313: Evaluation of CHOP plus involved field radiotherapy followed by yttrium-90 ibritumomab tiuxetan for stages I, IE, and non-bulky stages II and IIE, CD20 positive, high-risk localized, aggressive histologies of non-Hodgkin's lymphoma, phase II
Biogen Idec/114-NH-301 H07-030: A phase III, randomized, double-blind study of galiximab in combination with rituximab compared with rituximab in combination with placebo for the treatment of subjects with relapsed or refractory, follicular non-Hodgkin's lymphoma
S0515: Phase II trial of standard dose cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) and rituximab plus bevacizumab for advanced stage diffuse large B-cell NHL
BioCryst BCX1777-203 (H08-083): Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
SWOG S0350: Phase II trail of CISPLATIN plus ETOPOSIDE plus GEMCITABINE plus SOLUMEDROL (PEGS) in peripheral t-cell non-Hodgkin’s lymphoma (H08-085)
Astellas 155-CL-009 (H08-019): A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects
MYELOMA STUDIES
S0434: A phase II trial of bay 43-9006 (sorafenib)(NSC-724772) in patients with relapsing or resistant multiple myeloma previously treated wtih bortezomib
H08-013: Phase 1/2 study of Velcade (bortezomib), dexamethasone, and revlimid (lenalidomide) versus Velcade, dexamethasone, cyclophosphamide, and revlimid in subjects with previously untreated multiple myeloma
RENAL STUDIES
Wyeth 3066K1-404-WW (H08-103): A randomized trial of Temsirolimus and Sorafenib as second line therapy in patients with advanced RENAL cell carcinoma who have failed first line Sunitinib therapy
FEMALE CANCER PATIENTS
CCCWF 97106: A randomized study to determine whether Arginmax improves the sexual function and quality of life in female cancer patients (H08-041)
Clinical Trials
We are actively participating in clinical trials and research for our cancer patients. Newly developed treatments or investigational drugs may reduce tumor size and eliminate symptoms better than treatments currently available.
Patients are asked if they would like to participate in our clinical trials to evaluate new cancer prevention and treatment choices. Participation is completely voluntary. Ask the doctor about clinical trials at your visit.
See the patient information on Clinical Trials at the Feist-Weiller Cancer Center. Additional information is available for medical professionals. For more information about ongoing clinical trials at the Feist-Weiller Cancer Center, please call us toll-free at 1-866-LSU-FWCC (578-3922) or (318) 813-1410.