• Cancer Clinical Trials

  • Trial nameTitle of studyEligibility criteria
    CALGB 90601A randomized Double Blind Phase 3 Study comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in patients with advanced transitional cell carcinomaMetastatic or unresectable transitional cell carcinoma of the urinary tract; may not have received any combination of systemic chemotherapy for met disease
    S1314 (COXEN)A Randomized Phase II Study of Co-Expression Extrapolation with Neoadjuvant chemotherapy for Localized, Muscle Invasive Bladder CancerUrothelial cancer of the bladder Stage cT2-T4aN0M0. Clinical stage based on TURBT sample and imaging; Must undergo a cystoscopy and TURBT as part of staging Mus plan to remove at least 12 nodes with surgery; PS 0-1 No prior chemo for urothelial cancer
    CCCWFU 97509A phase II Double Blind Feasibility Study of Armodafinil for Brain Induced FatiguePrimary brain tumor; total of 4500 brain XRT in at least 25 fraction with 150cGY/Fraction planned
    RTOG 1205Randomized phase II trial of concurrent bevacizumab and re-irradiation versus bevacizumab alone as treatment for recurrent glioblastomaGlioblastoma or variant; Surgical or radiographic evidence for tumor progression by MRI withing 14 days of registration; 6 months or greater between completion of prior radiotherapy and registration or New area outside original fields or Histologic confirmation of tumor through biopsy or resection or nuclear imaging; Prior history of CNS radiation of 60 Gy in 30 fractions or 59.4 in 1.8 Gy Fraction or equivalent or lower doses
    Breast Cancer, Advanced or Recurrent
    NRG BR0003

    A Randomized Phase III Trial of Adjuvant Therapy comparing Doxorubicin plus Cyclophosphamide followed by Weekly Paclitaxel with or without Carboplatin for node positive or high risk node negative triple negative invasive breast cancer

    • Unilateral invasive adenocarcinoma of the breast
    • pT1-3; pN0,pN1; pN2a, pN2, pN3 or pMN3b; If pN0 must be >3cm;
    • Her2 Negative
    • ER and PR negative
    • Mastectomy or lumpectomy
    • No more than 60 days since surgery
    S1222Fulvestrant Alone versus Fulvestrant and Everolimus versus Fulvestrant, Everolimus and Anastrozone: A Phase III Randomized Placebo Controlled trial in postmenopausal patients with hormone receptor positive Stage IV breast cancerInvasive breast cancer; ER+; PR+; HER-2 Neu-;Postmenopausal; measurable or evaluable disease; No prior chemo or hormone therapy for metastatic disease; Prior adjuvant or neoadjuvant allowed
    sysTHERAn observational cohort study of treatment patterns and outcomes in patients with HER2 positive metastatic breast cancerHER2+MBC within last 6 months; no prior treatment more than 6 months before entry
    E2112A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor Positive Advanced Breast CancerER and/or PR positive adenocarcinoma breast; HER2 IHC3+, ISH is greater than 2.0, or average HER2 copy number is greater than 6.0 per cell are not eligible.; post menopausal; male or female; Must meet at least one of the following: Disease progression after nonsteroidal AI use in met setting or relapse while on or within 12 months of end of adjuvant non steroidal AI therapy with no prior or less than 4 weeks of endocrine therapy for met disease
    Breast Cancer, Invasive
    A221102Randomized Double Blind Placebo Controlled Study of Subcutaneous testosterone in the adjuvant treatment of post menopausal women with Aromatase inhibitor induced arthralgiasReceiving Anasrozole or letrozole for at least 21 days; BMI between 18 and 32 kg/m2; must have both ER and PR positive tumors and both must be >30% positive; must be postmenopausal > 12 months; > 5 out of 10 arthralgias
    NSABP B47A 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; pN2a, 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 S1007A 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 lessNode 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
    Aphinity (BIG 4-11)A Randomized multicenter, double blind placebo controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER-2 positive primary breast cancerPatients with positive nodes any pT except T0; for node negative tumor must be > 1.0 cm or 0.5-1.0 cm and at least one of the following Histologic grade 3 OR Negative for ER and PgR or age <35; synchronous bilateral invasive disease are eligible as long as both lesions HER 2-positive; 3-7 weeks post op; No T4 or inflammatory lesions
    B028407A randomized, multicenter, open label phase III trial comparing Trastuzumab plus Pertuzumab plus a taxane following anthracyclines versus trastuzumab emtansine plus pertuzumab following anthracyclines as adjuvant therapy in patients with operable HER2-Positive Primary Breast CancerNon Metastatic; HER-2 Positive; Known Hormone receptor; surgically resected; Pathological staging; pN>1 any tumor size except T1 and any hormone receptor; node negative with pathological tumor size >2.0 cmAND negative for ER and PR; Synchronous tumors eligible if both lesions are HER2 positive; No more than 9 weeks from surgical resection;
    A0421202A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Ritiuxmiab versus Ibrutinib alone in untreated older patietns (> 65 years of age) with Chronic Lyphocytic LeukemiaCLL in accordance with IWCLL 2008 criteria >5000/uL B Lymphocytes in peripheral blood; leukemic cells must be small mature lymphocytes and prolyphocytes must not exceed 55% of blood lymphocytes; CLL cells on immunophenotype must reveal a clonal B cell population which express B Cell surface markers of CD19 and CD20 as well as T Cell Antigen CD5. Must be intermediate or high risk Rai stage CLL. Must meet criteria for treatment by at least one of the following: evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia; massive, progressive or symptomatic splenomegaly; massive nodes or progressive or symptomatic lyphadenopahy; autoimmune anemia or thrombocytopenia that has poorly responsive to standard therapy; constitutional symptoms which include any of the following (Unintentional weight loss of 10% or more within 6 months; significant fatigue; fever >100.5 for 2 weeks or more without infection; night sweats > 1 month without evidence of infection; No prior therapy for CLL. Age >65; ECOG
    Colorectal Cancer
    CALGB 80702A Phase 3 Trial of 6 versus 12 Treatments for Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage 3 colon cancerCompletely 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
    MPR-1NSABP Patient registry and Biospecimen Profiling RepositoryMetastatic colorectal cancer; tissue block available; age 18 years or older; life expectancy of >6 months
    PLIANTA double blinded randomized three armed phase II trial of PledOx in two different doses in combination with FOLFOX6 compared to placebo + FOLFOX6 in patients with advanced metastatic colorectal (stageIV) cancerStage IV; may have received up to 3 lines of chemotherapy, with may include fluropyrimidine, irinotecan, and targeted therapies; evaluable disease; NO CNS mets;
    E7208A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, KRAS Wild Type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapymeasurable disease adenocarcinoma of the colon or rectum K-ras must be wild type (not mutated). Must have had prior first line therapy with oxaliplatin-based Fluoropyrimidine containing chemotherapy and bevacizumab for metastatic colorectal cancer Registration within 42 days of evidence of progression No surgery within 28 days of randomization

    Stivarga Management Amelioration Resorting Technology: Does Physician Education Infuence side effect management and does it increase time on treatment in the absence of progression? A phase 4 open label trial with regrafenib in metastatic colorectal cancer

    • Metastatic CRC for which decision has been made for regorafinib
    • Previously treated with Fluoropyrimidine, oxaliplatin and irinotecan therapy, an anti VEGF and if KRAS wild type, an EGFR therapy;
    • PS -1
    • CrcL: =30 L/min
    Esophageal Cancer
    RTOG 1010A Phase 2 Trial evaluating the Addition of Trastuzumab to Trimodality Treatment of HER-2 Overexpressing Esophageal AdenocarcinomaPrimary esophageal cancer of the mid, distal, or esophageal junction; Extension into stomach up to 5 cm is allowed;  Tissue submitted for HER2 central review; PS 0-2
    CALGB 80803A randomized Phase II Trial of PET Scan Directed Combined Modality Therapy in Esophageal CancerSurgically resectable, adenocarcinoma of the esophagus including the GE junction; EUS staging; T1N1-2 M0 or T2-4, N any; M0 must be detectable FDG uptake on baseline PET/CT Scan of the primary tumor; ECOG 0-1
    RTOG 1203A Randomized Phase III Study of Standard vs. IMRT Pelvic Radiation for Post Operataive Treatment of Endometrial and Cervical Cancer (TIME-C)Endometrial or cervical cancer within 90 days; hysterectomy within last 49 days; staging (CT/MRI/PETCT Chest or Abdomen within 90 days); Endometrial with plans for weekly Cisplatin; <50% of myometrial invasion, gr 3 adenomocarcinom without uterine serous carcinoma or clear cell histolology; > myometrial invasion grade 1-2 adenomcarcinoma without USC or clear cell histology  Endometrial to be treatment with or without cisplatin: > 50% myometrial invasion, gr 3 including USC and clear cell carcinoma, FIGO 2009 stage II endometrial cancer of any grade and IIC1; Cervical Cancer to be treated with or without weekly cisplatin: 1/3 or more stromal invasiton; lymph vascular space invasion; large clinical tumor diameter (>4cm) or has the patients been treated with simple hysterectomy with negative margins and negative nodes on scans; Cervical cancer to be treated with weekly cisplatin: positive pelvic nodes resected or microscopic parametrial invasion with negative margins.
    GOG 0213A Phase III randomized controlled clinical trial of carboplatin and paclitaxel alone or in combination with bevacizumab followed by bevacizumab followed by bevacizumab and secondary cytoreductive surgery in platinum sensitive, recurrent ovarian peritoneal primary and fallopian tube cancerCandidate for cytoreductive suregery Epithelial ovarian cancer, peritoneal primary or fallopian tube cancer which is now recurrent Serous adenocarcinoma; endometroid adenocarcinoma, mucinous adenocarcinoman undifferentiated carcinoma, clear cell carcinoma; mixed epithelial carcinoma; transitional cell carcinoma; malignant Brenners’s tumor; or adenocarcinoma not otherwise specified; Must have had complete response to front line platinum –taxane based therapy (at least three cycles) Treatment free interval without clinical evidence of progression of at least 6 months from completion of front line chemo. Must not have received more than one previous regimen of chemo; No previous radiation to abdomen or pelvis
    Head and Neck
    RTOG 0920A Phase 3 Study of Postoperative Radiation Therapy  (IMRT) +/- Cetuximab for locally advanced resected head and neck cancerSquamous 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 1008A Randomized Phase 2 Study of Adjuvant concurrent radiation and chemotherapy versus radiation alone in resected high risk malignant salivary gland tumorsHigh 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.
    E1311A Randomized, Placebo Controlled Phase II trial of Afatinib as Adjuvant Therapy Following Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma at High Risk of RecurrencePS 0-1; Path evidence of persistent lymph node disease with variable tumor cells following primary concurrent chemoradiotherapy of locoregionally advanced (Stage III/IV)HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx; Must have undergone a neck dissection following completion of chemoradiotherapy; At least 6 weeks and no more that 16 weeks from completion of chemoradiation;
    REVEALProspective Non interventional Study of Disease Progression and Treatment of Patients with Polycythemia Vera in United States Academic or Community Clinical Practices
    • Diagnosis of PV
    • Willing and able to complete forms
    • Under care of PV, including but not limited to ASA 81 mg or greater, antithromotic therapy, PHL, HU, interferon, busulfan, angrelide
    GILEAD US-339-0102A Phase 2 Open Label Study Evaluating the Efficacy Safety Tolerability and Pharmacodynamic of GS9973 In Subjects with Relapsed or Refractory Hematological Malignancy
    • B cell iNHL, DLBCL, MCL or CLL
    • If iNHL confirm one of the following FLgrade 1, 2 or 3a, SLLL; LPL/WM or MZL (spenic, nodal or extranodal)
    • Prior treatment for lymphoid malignancy and now requiring treatment for progressive disease
    • Measurable progressive disease
    Lab Studies
    ViewVeristrat Observational Study of Patients with Non Small Cell Lung CancerMale 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 ResearchClinical Research Sample CollectionCancer Targeted will change periodically based on sponsor need.  
    PPAPhysicians Plasma AllianceBlood and urine for patients on monthly listing
    Lung Cancer, Adjuvant

    Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials

    • A151216 screening trial
    • A081105 Erlotimib tiral (EGFR Mutations)
    • E4512 Crizotinib Trial (ALK mutations)
    • Clinical stage IB(.4cm), II or IIIA, resectable non-squamous cell NSCLC
    • ECOC 0-1
    • No neo adjuvant treatment
    • No interstitial fibrosis or lung disease
    • No prior treatment with EGRF targeting mutation or ALK rearrangement
    • No patients with local genotyping showing wild type EGFR and ALK
    • No patients with local genotyping showing KRAS mutation
    Lung Cancer, Neoadjuvant
    RTOG 0839A Randomized Phase II Study of Preoperative chemoradiotherapy +/- Panitimuab followed by consolidation chemotherapy in potentially operable locally advanced (Stage IIIa, N2) Non Small Cell Lung Cancer3A N2+ disease; NSCLC; Diagnosed within 12 weeks of registration; No pleural effusion; FEV1 at least 2.0
    Lung Cancer, Non Small Cell
    G027912A 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 cancerUntreated stage IV or Recurrent NSCLC; Arms A and B squamous cell and Arms C and D Non Squamous cell; Measurable Disease

    A Phase III, Open Label, randomized study of MPDL3280A (Anti PDL1 Antibody) compared with Cisplatin or Carboplatin + pemetrexed for PD-L1 selected, chemotherapy naïve patients with stage IV Non Small Cell Lung Cancer

    • Stage IV Non Squamous NSCLC;
    • No prior treatment for stage IV unless had a previously detected sensitizing EGFR mutation or ALK fusion oncogeneThey must have been treated with EGFR TKI (erlotinib, gefitinib)/ALK Inhibitor (crizotinib, etc)  and experienced disease progression
    • Pts who received prior neoadjuvant or chemoradiotherapy for non metastic disease must have experienced a treatment free interval of at least 6 months since the last chemo or chemoradiotherapy cycle.
    • Prior treated asymptomatic brain mets if specific criteria met:  off steroids, anticonvulsants stable, no progression of brain mets,
    • Tumor PD-1 expression (TC3 or IC3) as performed by central lab

    A Phase III, open label, randomized study of MPDL3280A (anti-PDL1 antibody) compared with gemcitabine +Cisplatin or Carboplatin for PD-L1-selected, chemotherapy-naïve patients with stage IV squamous non small cell lung cancer

    • Stage IV squamous NSCLC
    • Treated asymptomatic CNS mets eligible
    • Tumor PD-L1 expression (TC3 or IC3) as determined by IHC assay performed by a central laboratory
    • Pts who received prior neoadjuvant or chemoradiotherapy for non metastic disease must have experienced a treatment free interval of at least 6 months since the last chemo or chemoradiotherapy cycle.
    • No prior chemo for Stage IV NSCL unless patient had a previously detected sensitizing EGFR mutation or ALK fusion oncogene. They must have been treated with EGFR TKI (erlotinib, gefitinib)/ALK Inhibitor (crizotinib, etc) and experienced disease progression
    E5508A 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 CancerNSCLC with predominantly squamous cell stage IV; no prior chemo for stage IV; prior adjuvant o’k; no brain mets; measurable or non measurable disease; no cavitary lesions
    OAM4971GA Randomized Phase III Multicenter double blind placebo controlled study evaluating the efficacy and safety or MetMAb in Combination with Tarceva in patients with MET Diagnostic Positive Non Small Cell Lung Cancer Who have Received Standard Chemotherapy for Advanced or metastatic diseaseA Randomized Phase III Multicenter double blind placebo controlled study evaluating the efficacy and safety or MetMAb in Combination with Tarceva in patients with MET Diagnostic Positive Non Small Cell Lung Cancer Who have Received Standard Chemotherapy for Advanced or metastatic disease
    Lung Cancer, Small Cell
    CALGB 30610A Phase 3 comparison of Thoracic Radiotherapy regimens in patients with limited stage small cell lung cancer also receiving Cisplatin and EtoposideLimited stage;  no contralateral hilar or supraclavicular nodes; no pleural effusion; no pericardial effusion; measurable disease
    E2511Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer
    • Extensive Stage
    • Small Cell Lung Cancer
    • Measurable Disease
    • ECOG PS 0-1
    • No CNS mets or history of CNS mets
    • No prior chemo or biologic therapy for small cell lung cancer
    • Must be able to swallow pills
    E1411 Intergroup Randomized Phase II Four Arm Study in Patients > 60 with previously untreated mantle cell mantle lymphoma of therapy with :  Arm A = Rituximab + Bendamustine followed by Rituximab Consolidation;  Arm B= Rituximab + Bendamustine + Bortezomib followed by Rituximab Consolidation;  Arm C= Rituximab + Bendamustine Followed by Lenalidomide + Rituximab Consolidation or Arm D= Rituximab + Bendamustine + Bortezomib followed  by Lenalidomide + Rituximab ConsolidationMantle cell lymphoma with documented with cyclin D1 by IHC stains and/or t (11;14) by cytogenetics or FISH; At least one objective measurable disease parameter within 4 weeks of registration
    E1412Randomized Phase II Open Label Study of Lenalidomide RCHOP vs RCHOP in patients with newly diagnosed Diffuse Large B cell LymphomaDLBCL expressing CD20 antigen with known primary mediastinal large b cell lymphoma are excluded; Stage II bulky disease (mass size of more than 10 cm) , stage III or IV; Measurable disease; Ejection fraction of > 45%
    GS-US-313-0124A Phase 3, Randomized, Double Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Idelalisisb in Combination with Rituximab for previously Treated Indolent Non Hodgkins LymphomaB cell iNHL (follicular lymphoma gr 1,2, 3a, Small lymphocytic lymphoma with ALC < 5 x 109/L; lymphoplasmacytoid lymphoma/waldenstrom macroglobulinemia; Marginial zone Lymphoma; Relapsed, radiographically measurable nodal or extranodal iNHL;  > regimen containing anti-CD20; Discontinual of all therapy of cancer >6 weeks prior to randomization; karnofsky > 60; Ineligile: Lack of CR or PR during Rituximab containing chemoimmunotherapy comprising > 2 does of 375 mg/m2 or occurrence of PD < 6 months of completion of single agent rituximab therapy comprising >4 doses of 375 mg/m2 or occurrence of PD <6 months of the completion of rituximab containing chemoimmunotherapy comprising > 2 does of > 375 mg/m2
    GS-US-313-0125A Phase 3, Randomized, Double Blind, Placebo-Controlled Study evaluating the efficacy and safety of Idelalisib (GS-1101) in combination with Bendamustine and Rituximab for Previously Treated Indolent Non Hodgkin LymphomaB Cell iNHL with: Follicular lymphoma gr 1, 2, or 3a; Small lymphocytic lymphoma with ALC ,5 X 10 9/L at diagnosis; Lymphoplasmocytoid Lymphoma/Waldenstrom Macroglobulinemia; Marginal Zone Lymphoma; Relapsed, radiographicallly measurable nodal or extranodal iNHL; Prior Treatment for lymphoid malignancy comprising >1 regimen containing a therapeutic anti-CD20 antibody (Rituxan) administered for 2 doses of antibody; Prior treatment for lymphoid malignancy comprising >1 regimen containing a therapeutic chemotherapy administered for >2 cycles of treatment; Discontinuation of all therapy for > 6 weeks prior to randomization.
    S1320A Randomized Phase II Trial of Intermittent versus continuous Dosing of Dabrafenib and Trametinib in BRAF mutant Melanoma
    • Stage IV or Unresectable Stage III BRAF mutant Melanoma (V600E or V600K)
    • CT neck, chest, abdomen and pelvis required
    • No prior BRAF and MEK inhibitor
    • No Brain Mets unless treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme reducing anti-epileptic drugs or corticosteroids for at least 7 days prior to registration
    • No anti-cancer drug within 28 days prior to registration and must not have received any nitrosureas or mitomycin C within 42 days prior to registration
    SWOG S0905A Phase I Randomized Phase II Study of Cediranib Versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural MesotheliomaMalignant 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
    Multiple Myeloma
    ECOG E3A06Randomized Phase III trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High Risk Smoldering Multiple MyelomaAsymsptomatic high risk smoldering Multiple myeloma within past 12 months as confirmed by bone marrow plasmacytosis with >10 % plasma cells or sheets of plasma cells within last 4 weeks; Abnormal serum free light chain ratio (,0.125 or >8.0) by serum FLC assay; must have measurable levels of M protein; No lytic lesions on skeletal surveys and no hypercalcemia
    PANEXExpanded Treatment protocol of pandonostat in combination with Bortezomib and dexamethasone in patients with Multiple Myleoma who have had at least 1 prior line of treatment
    • Replapsed +/or refractory Multiple myeloma with at least 1 prior treatment
    • Patient who have received allogenic stem cell transplant and do not have active graft versus host disease requiring immunosuppressive treatment are eligible
    • Measurable disease
    RTOG 1201 Suspended A Phase II Randomized Trial of High Versus Standard Intensity local or systemic therapy for unresectable pancreatic cancerAdenocarcinoma of the pancreas; diagnosed in last 45 days; tumor less than 7 unresectable radiographically within 30 days prior to step 1 registration; PS 0-1; No prior systemic chemotherapy
    E2212A Randomized, Double Blinded, Placebo-Controlled Phase II Study of Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the LiverMet low or intermediate grade pancreatic neuroendocrine tumors to the liver; must have recovered from R0 or R1 resection of all disease; must be within 4 to 8 weeks from completion of surgery; prior treatment with sunitinib or chemo are allowed if greater than 30 days prior to randomization; Must not have received Everolimus;
    RTOG 0924Androgen 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 + T1c-T2b +PSA >20

    No prior surgery, radiation, hormone ablation

    RTOG 0815A Phase 3 prospective randomized trial of dose escalated radiotherapy with or without Short term Androgen deprivation therapy for patients with intermediate risk prostate cancerProstate 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
    RTOG 0534A 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 prostatectomyAdenocarcinoam 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 90203A 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 cancerAdenocarcinoma of the prostate; clinically localized disease (T1-3a) and no radiographic evidence of met disease; nomogram predication of 60%; No prior treatment for prostate cancer including surgery (TURP), pelvic node dissection, radiation, or chemotherapy; may have received up to 3 months ADT
    SWOG S1216A phase III randomized trial comparing androgen deprivation therapy and TAK-700 with Androgen Deprivation + Bicalutamide in patients with newly diagnosed metastatic hormone sensitive prostate cancerAdenocarcinoma of the prostate with distant mets of soft tissue or bony mets prior to initiation o the androgen deprivation; no brain mets; may have received prior neoadjuvant and/or adjuvant hormonal therapy, but must not have last more than 36 months; must not have received or be planning to be receiving concomitant ketoconazole, aminogluethimide or abiraterane or Enzalutamide; no prior chemo; palliative xrt ok; may have had surgery; no more than 30 days of medical castration prior to registration
    UVA Hypofractionated (Norton Only) Hypofractionated Post Prostatectomy radiotherapy for prostate cancer to reduce toxicity and improve patient convenience: A Phase I/11 TrialAdenocarcinoma of prostate post surgical management; Confirmation of detectable PSA after surgery; Presence of extracapsular extension, seminal vesicle invastion or positive surgical margin if post op PSA in undetectable; previous androgen suppression therapy allowed if it was completed at least 3 months from study treatment; Chemotherapy allowed but must be greater than 4 weeks
    Renal Cell Carcinoma
    EVEREST SWOG S0931Everolimus for Renal Cancer ensuing surgical therapy, A Phase III StudyRenal cell carcinoma with intermediate or high risk; Undergone Full Resection; Bilateral renal tumors are not eligible
    A031203Randomized Phase II Study Comparing Cabozantinib with commercially supplied sunitinib in Patients with Previously untreated locally advanced or metastatic renal cell carcinomaLocally advanced or metastatic renal cell carcinoma with clear cell component; intermediate or poor risk; no evidence of cavitary pulmonary lesion; no prior systemic treatment for RCCC; no major surgical procedure in 6 weeks; must have measurable disease; XRT must be completed within 90 days before registration; No brain mets
    E2810Randomized, Double Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastaitc Renal Cell Carecinoma who have no evidence of Disease Following MetastatectomyRenal cell carcinoma with clear cell componenet;pure papillary and chromophne histologies are excluded; must have underone nephrectomy or partial nephrectomy; must have undergone surgical resection to remove one or mor sites of metastatic disease with successful removal of all known sites 2-12 weeks prior to randomization; No evidence of disease on post operative imaging CT and.or MRI conducted withine 4 weeks prior to randomization
    Survival and Quality of Life
    VCU Day and Night Study(Norton Cancer Center Only) Day and Night Study of Lifestyle and Cancer Survival StudyAge: 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
    N08C9(Opening August 2012) Phase III, Randomized, Study of Sulfasalazine versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation TherapyAbility to complete questionnaires; life expectancy of 6 months; diagnosis of cancer  that supports radiation to the pelvis with minimum dose of 4500cGy with or without 5FU, Capecitabine or Oxaliplatin is planned.  Not receiving Leucovorin. 
    99311Randomized Placebo Controlled Phase 2 Pilot Study of Memantine for Smoking Cessation among Cancer SurvivorsStage I or II NSCLC or non metastatic breast prostate or colorectal; 6 months post definitive treatment; Smoked 100 cigarettes over lifetime and who, at the time of first interview , smoked 10 or more cigarettes per day on most days over past month
    20130110 CABSProspective Study of the Relationship between chemotherapy dose intensity and mortality in Early Stage (I-III) Breast cancerStage I-III; 1st or new Regimen; receiving high risk or intermediate risk chemotherapy and prophylactic G-CSF
    A221102Randomized Double Blind Placebo Controlled Study of Subcutaneous testosterone in the adjuvant treatment of post menopausal women with Aromatase inhibitor induced arthralgiaReceiving Anasrozole or letrozole for at least 21 days; BMI between 18 and 32 kg/m2; must have both ER and PR positive tumors and both must be >30% positive; must be postmenopausal > 12 months; > 5 out of 10 arthralgia
    Kaitlin B028407A randomized, Multicenter, open label, phase III trial comparing Trastuzumab plus Pertuzumab plus a Taxane following anthracyclines versus Trastuzumab Emtansine Plus Pertuzumab following Anthracyclines as Adjunct therapy in patient with operable HER2-positive primary breast cancerECOG 1 HER2 Positive; Known hormone receptors; post op; must have had CLNB and/or axillary dissection; Node positive disease, any tumor size except T0; and any hormonal status; Node negative if tumore size 2.0 cm AND negative ER and PR; synchronous bilateral invasive; No more than 9 weeks between surgery and randomization; Baseline LVEF > 55%;
    E1Z11A Cohort Study to Evaluate Genetic Predicators of Aromatase Inhibitor Musculoskeletal SymptomsPost menopausal; ER/PR receptor positive; must have completed recommended local therapy and adjuvant therapy for breast cancer; Stages 1-3; Must have not received pirior AI therapy with exemestane ; letrozole; or anastrozole as adjuvant therapy; prior tamoxifen as adjuvant is allowed. Not currently taking analgesics for ongoing chronic condition
  • Additional resources for clinical trials

    Several web-based resources have been developed to facilitate patient access to and information about clinical trials performed in hospitals and clinics around the country. Searchable databases of national clinical trials are also available through the National Cancer Institute and the Southeast Cancer Control Consortium.

  • How do I get started?

    The Wellmont Cancer Institute offers clinical trial opportunities at our Kingsport, Bristol and Southwest Virginia cancer centers. If you're looking for more information or have questions about this program, please contact us.