Clinical Trials Department
May 2012

Clinical Trials Database
Trial Title Eligibility Criteria
Lab Studies
View Veristrat Observational Study of Patients with Non Small Cell Lung Cancer Male or female over 18 years of age; Stage IIIB or IV NSCLC that has progressed after at least one standard, first line chemotherapy regimen or not eligible or an appropriate candidate for standard, first line chemotherapy; Has not been previously treated with erlotinib, gefitinib, cetuximab, panitimumab or any investigational agent that target EGFR
VMU Research Clinical Research Sample Collection Cancer Targeted will change periodically based on sponsor need.
Survival and Quality of Life
VCU Day and Night Study Day and Night Study of Lifestyle and Cancer Survival Study Age: 18-70; Male or female; Stage I or II Lung Breast Colorectal or prostate cancer; At least 6 months since end of treatment (taking hormones still ok) Concurrent malignancies o'k as long as both stage I or II. No maximum since diagnosis;
Breast Cancer Prevention
CALGB 70806 Vitamin D and Breast Cancer Biomarkers DCIS: Her2 Neu positive as determined by central testing; Lumpectomy; No more than 12 days from surgery; must be N0: p N0 (i); pN0 (i+)
Breast Cancer
Invasive
MA.32 A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer Histologically confirmed invasive breast cancer within past 12 months.
Stage:
  • pT1c, pN0, and one of the following: Gr 3, lympohvascular invasion, ER-, PR-, HER2+, oncotype > 25, pT2-3, pN0
  • pT2-3, pN0
  • pT1-3, pN1-3
Must have sentinel node biopsy or axillary dissection. Definitive surgery and/or chemotherapy have been completed at least within 4 weeks prir to randomization. Age less than 75
NSABP B49 A Phase III Clinical Trial Comparing the Combination of Docetaxel plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node Positive or High Risk Node Negative Breast Cancer Female; ECOG 0-1; Unilateral invasive adenocarcinoma of the breast; HER2-negative; Stage: pT1-3; p N0, N1; N2a, pN3a, pN3b;
If pN0 must meet one of the following: ER – and PgR -; Patholgic size >2.0cm or T1c and ER + and either grade 3 or Oncotype Dx score >25;
NSABP B47 A Randomized Phase 3 adjuvant therapy comparing chemotherapy alone (six of AC or four cycles of AC followed by weekly paclitaxel) to chemotherapy plus Trastuzumab in Women with Node Positive or High Risk Node Negative HER 2 Low Invasive Breast Cancer Female; PS 0-1; Invasive breast cancer;
pT1-3;pN0, pN1; PpN2a, pN2b; pN3a or pN3b;
If pN0 must be one of the following:
  • pTx and ER- and PgR neg
  • pT2 and ER+ and either grade 3 or Oncotype Dx ≥ 25;
Her 2 status evaluated prior to randomization as HER2 low IHC staining of 1+ (ISH testing is not required) or 2+ FISH or CISH must also be performed and must indicate no more than 84 days post op
SWOG S1007 A Phase 3 Randomized Clinical Trial of Standard Adjuvant Endocrine therapy +/- chemotherapy in pts with 1-3 + nodes, Hormone Receptor + and HER2 negative breast cancer with recurrence Score of 25 or less Node Positive (1-3); invasive breast cancer; ER+ and/or PR status; HER 2 negative ; must NOT have inflammatory: M0; Oncotype Dx within 28-56 days after definitive surgery; Oncotype Dx if performed before study entry must be 25 or less; PS 0-2;
Advanced or Recurrent Breast
SWOG S0800 A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel with or without Bevacizumab, either preceeded by or followed by every two week Doxorubicin and Cyclophosphamide Plus Pegfilgrastim as Neoadjuvant Therapy for Inflammatory and locally Advanced Her-2New Negative Breast Cancer HER 2 Negative Inflammatory Breast or HER 2 Locally advanced breast cancer Stage 3a or b and known receptor status: must not have had prior chemotherapy, radiation, or biological therapy; PS 0-2; no history of stroke or cardiac event in the last 12 months.
N0733 A Phase 2 Trial of Capecitabine and Lapatinib with or without IMC-A12 in patients with HER2 Positive Breast Cancer treated with Trastuzumab and an Anthracycline and/or Taxane Breast Cancer that has progressed after treatment: 1-2 prior chemo; prior hormonal therapy allowed; HER2 positive; measurable disease;
Lung Cancer
Adjuvant
E1505 A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for patients with completely resected stage Ib (>4cm)- IIIA Non Small Cell Lung Cancer Surgery within 6-12 weeks of randomization; chemotherapy at the discretion of the investigator from 3 regimens: Vinorelbine/Cisplatin; Docetaxel/Cisplatin; Gemcitabine/Cisplatin;
Lung Cancer
Neoadjuvant
RTOG 0839 A Randomized Phase II Study of preoperative chemoradiotherapy +/- Panitumumab followed by consolidation chemotherapy in potentially operable locally advanced (Stage IIIa, N2+) Non Small Cell Lung Cancer 3A N2+ disease; NSCLC; diagnosed within 12 weeks of registration; No pleural effusion; FEV1 at least 2.0
Lung Cancer (Non Small Cell)
G027912 A Phase II, Double Blind, Placebo Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Caroplatin/Paclitaxel/Bevacizumab with and without GDC-0941 in patients with previously untreated advanced or recurrent non small cell lung cancer. Untreated stage IV or Recurrent NSCLC; Arms A and B squamous cell and Arms C and D Non Squamous cell; Measurable Disease;
CALGB 30801 A Randomized Phase 3 Double Blind trial evaluating Selective COX-2 inhibition in COX-2 expressing Advanced Non Small Cell Lung Cancer Stage IV and Selected Stage IIIB; No prior treatment; NSCLC
E5508 A Randomized Phase 3 Study of Maintenance Trial with Bevaciuzumab, Pemetrexed or a combination of Bevacizumab and Pemetrexed following Carboplatin, Paclitaxel and Bevacizumab for Adjuvant Non Small Cell Lung Cancer NSCL with predominantly squamous cell stage IV; no prior chemo for stage IV; prior adjuvant o’k; no brain mets; measurable or non measurable; no cavitary lesions;
Small Cell Lung Cancer
CALGB 30610 A Phase 3 comparison of Thoracic Radiotherapy regimens in patients with limited stage small cell lung cancer also receiving Cisplatin and Etoposide Limited stage ; No contralateral hilar or supraclavicular nodes; no pleural effusion; no pericardial effusion; measurable disease
Mesothelioma
SWOG S0905 A Phase I Randomized Phase II Study of Cediranib Versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma Malignant pleural mesothelioma; measurable or non measurable disease; must not have received prior systemic therapy; May have had surgery and radiation if greater than 28 days; PS 0-2;
Colorectal Cancer
NSABP P5 Statin Polyp Prevention Trial in Patients with Resectable Colon Cancer Stage 1 or 2 Adenocarcinoma of the Colon; surgically resected with curative intent within 1 year prior to randomization; must have completed adjuvant therapy if planned; colonoscopy within 180 days of randomization
CALGB 80702 A Phase 3 Trial of 6 versus 12 Treatments for Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage 3 Colon Cancer Completely resected Stage 3 colon cancer; at least one pathologically confirmed positive node; synchronous colon lesions are eligible; No NSAIDS use at any dose and no aspirin use exceeding 100 mg/day
Esophageal Cancer
RTOG 1010 A Phase 2 Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER-2 Overexpressing Esophageal Adenocarcinoma Primary esophageal cancer of the mid, distal, or esophagogastric junction; Extension into stomach up to 5 cm is allowed; Tissue submitted for HER 2 central review; PS 0-2;
CALGB 80803 A Randomized Phase II Trial of PET Scan Directed Combined Modality Therapy in Esophageal Cancer Surgically Resectable, adneocarcinoma of the esophagus including the GE junction; EUS staging; T1N1-2M0 or T2-4,Nany,M0; must have detectable FDG uptake on baseline PET/CT Scan of primary tumor; ECOG 0-1;
Hepatocellular
CALGB 80802 Phase 3 Randomized Study of Sorafenib Plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma Hepatocellular carcinoma; Locally advanced or metastatic; measurable disease; no prior adjuvant therapy with sorafenib or Raf/VEGFR inhibitors; other prior adjuvant is allowed if completed in > 6 months; no prior systemic therapy for metastatic disease
Prostate
RTOG 0924 Androgen Deprivation Therapy and High Dose Radiotherapy with or without Whole Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial Diagnosis within 180 days; Moderate to High Risk:
  • Gleason Score 7-10+T1c-T2b +PSA <50
  • Gleason Score 6 +T2c-T4 or >50% positive Biopsies + PSA<50;
  • Gleason Score 6 + T1c-T2b + PSA >20;
No Prior Surgery, Radiation; Hormone Ablation
RTOG 0815 A Phase 3 prospective randomized trial of dose escalated radiotherapy with or without Short term Androgen deprivation therapy for patients with intermediate risk prostate cancer Prostate cancer in the last 6 months; intermediate risk by one or more of the following: Gleason Score 7; PSA> 10 by<20; Clincial Stage t2b-T2c; clinically negative lymph node; PS 0-1
SWOG S1014 Abiraterone Acetate Treatment for prostate cancer patients with a rising PSA of More than Four Following Initial Androgen Deprivation Therapy, Phase II Adenocarcinoma of the prostate; must have M1 disease; Must be receiving androgen deprivation therapy prior to entering; Suboptimal response to ADT (declining PSA that fails to reach 4 ng/ml; the PSA must be observed between 6-9 months after the intitation of ADT; Rising PSA and progressive disease are not eligible
RTOG 0534 A Phase 3 trial of Short Term Androgen Deprivation with Pelvic Node or Positive Bed Only Radiotherapy (SPORT) in prostate cancer patients with rising PSA after Radical Prostatectomy Adenocarcinoma of the prostate with radical prostatectomy, N0 or Nx; post op PSA >0.2 and <2.0; T3N0/Nx; Gleason Score 8 or less; no prior radiation
CALGB 90203 A Randomized Phase 3 study of Neoadjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High Risk, Clinically localized prostate cancer Adenocarcinoma of the prostate; clinically localized disease (T1-3a) and no radiographic evidence of metastatic disease; nomogram prediction of 60%; No prior treatment for prostate cancer including surgery (TURP), pelvic node dissection, radiation therapy or chemotherapy; may have received up to 3 months of androgen deprivation;
Bladder
CALGB 90601 A Randomized Double Blind Phase 3 study comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin and Placebo in Patients with Advanced Transitional Cell Carcinoma Metastatic or unresectable transitional cell carcinoma of the urinary tract; may not have received any combination of systemic chemotherapy for met disease;
Renal Cell Carcinoma
EVEREST SWOG S0931 Everolimus for Renal Cancer ensuing surgical therapy, A Phase III Study Renal cell carcinoma with intermediate or high risk; Undergone Full Resection; Bilateral renal tumors are not eligible
Brain
CCCWFU 97509 A Phase II Double Blind Feasibility Study of Armodafinil for Brain Induced Fatigue Primary brain tumor; total of 4500 cGy Brain XRT; at least 25 fractions of 150 cGy/fraction
Head and Neck Cancer
RTOG 0920 A Phase 3 Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for locally advanced resected head and neck cancer Squamous cell of the head and neck (oral cavity, oropharynx, or larynx); Stage T1, N1-2, or T2-3, N0-2, M0 Including no distant mets; Laryngopharygoscopy within 8 weeks; gross total resection of primary tumor with curative intent must be completed within 7 weeks of registration; perineural invasion; lymphovascular invasion; single >3 cm or > 2 lymph nodes (all <6cm); Close Margin; t3 or microscopic T4a primary; T2 oral cavity cancer with 5 mm depth of invasion
RTOG 1008 A Randomized Phase 2 Study of Adjuvant concurrent radiation and chemotherapy versus radiation alone in resected high risk malignant salivary gland tumors High Grade mucoepidermoid carcinoma; salivary duct carcinoma or high grade adenocarcinoma; Surgically resected within 8 weeks; Pathological Stage T3-4; N1-3; or T1-2, N0 with ≤1mm positive margin.
RTOG 1016 A Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV Associated Oropharynx Cancer Pathologically proven Squamous Cell Carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); Measurable disease; Clinical Stage:
  • T1-2, N2a-N3 or
  • T3-4, any N
M);
Lymphoma
PIX 306 A randomized Multicenter Study Comparing Pixantrone+Rituximab with Gemcitabine + Rituximab in patients with aggressive B-cell Non Hodgkin Lymphoma Who Have Relapsed after Therapy with CHOP-R or an equivalent regimen and are ineligible for stem cell transplant DLBCL or DLBCL transformed from follicular lymphoma; Received RCHOP+rituximab or equivalent regimen; received at least 1 but not more than 3 prior therapies for NHL; Not eligible for High Dose chemotherapy and SCT; Measurable Disease;
Melanoma
E1609 A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 therapy versus high dose Interferon a-2b for Resected High Risk Melanoma Completely resected with the following stages: IIIB, IIIC, IV Stage IV must have normal LDH and wither distant skin, subcutaneous, lymph node or lung mets, but no other visceral melanoma; Patients with disease recurrence after adequate surgical excision of the original primary cutaneous melanoma are allowed as follows:
  • Recurrence in a regional node basin after prior complete lymph node dissection. Relapsed disease must be completely surgically resected with free margins
  • Recurrence in the form of in-transit or satellite mets or distant skin/subcutaneous, nodal or lung mets that are completely surgically resected with free margins
  • Recurrence in a regional lymph node basin. Relapsed disease has been completely surgically resected with free margins;
Patients with unknown primary melanoma who presents with cutaneous, subcutaneous, nodal and/or lung mets that are completely surgically resected with free margins are allowed.

Teresa Bailey, RN, BSN, OCN
423-578-8538 teresa.bailey@wellmont.org

BJ Sesney, LPN
423-578-8553 barbara.sesney@wellmont.org