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Clinical Trials at St. Mary

Oncology-Related Clinical Trials

(updated 7/14/2014)

BREAST

SMMC 10-005: NSABP B43 A phase III Clinical trial comparing Trastuzumab given concurrently with radiation therapy and radiation therapy alone for women with HER2 positive ductal carcinoma in situ resected by lumpectomy

 SMMC 11014: E2108 A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

SMMC-12004: NSABP B47/SMMC12004 A randomized phase III trial of adjuvant therapy comparing chemotherapy alone (six cycles of Docetaxel plus Cyclophosphamide or four cycles of Doxorubicin plus cyclophosphamide followed by weekly Paclitaxel) to chemotherapy plus Trastuzumab in women with node positive or high risk node-negative HER2-Low invasive breast cancer

SMMC 11020: RTOG 1005 A Phase III Trial of Accelerated whole breast irradiation with hypofractionation plus concurrent boost vs, standard whole breast irradiation plus sequential boost for early-stage breast cancer

SMMC 12006: E3108/SMMC12006 A phase II prospective trial correlating progression free survival with CYP2D6 activity in patients with metastatic breast cancer treated with single agent Tamoxifen

SMMC 12016: NeoAdjuvant Breast Registry - Symphony Trial (NBRST)

SMMC 12018: Prospective Registry of MammaPrint in Breast Cancer Patients with an Intermediate Score (PROMIS)

SMMC 13002:  Amgen Neulasta 20110148/SMMC13002: Randomized, single-blind study to estimate the effect of patient education on reported bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim

SMMC 13017: ABI-007-MBC-001 A Phase II/III Multi-Center, open label, randomized study of weekly NAB®- PACLITAXEL in combination with gemcitabine or carboplatin, compared to GEMCITABINE/CARBOPLATIN, as first line treatment in subjects with ER, PGR, AND HER2 negative (Triple negative) metastatic breast cancer

SMMC 13022: Celldex Protocol CDX011-04 A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The “METRIC” Study)

SMMC 14002: Amgen Neulasta NOLAN 20110147 Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim

 

HEAD AND NECK/LARYNX

 SMMC 11-016:  RTOG0920 A phase III study of postoperative radiation therapy (IMRT) +/- Cetuximab for locally advanced resected head and neck cancer

LUNG

SMMC 10-009: IMCL CP12-0917 An open-label, multicenter, randomized, phase II study of a recombinant human anti-VEGFR-2 monoclonal antibody, IMC-1121B in combination with platinum-based chemotherapy vs. platinum based chemotherapy alone as first line treatment of patients with recurrent or advanced non-small cell lung cancer (NSCLC)

SMMC-14007: BMS CA209153/SMMC 14007 A phase IIIB/IV safety trial of Nivolumab (BMS 936558) in subjects with advanced or metastatic Non-Small Cell Lung Cancer who have progressed during or after receiving at least one prior systemic regimen

PANCREATIC

SMMC-14011: INCB 18424-363 A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 2 Study)

SMMC 09-016:  RTOG 0815/SMMC 09016 A phase III prospective randomized trial of dose-escalated radiotherapy with or without short-term androgen deprivation therapy for patients with intermediate-risk prostate cancer

SMMC 08-014: RTOG 0534 A Phase III trial of short term androgen deprivation with pelvic lymph node or prostate bed only radiotherapy (SPORT) in prostate cancer patients with a rising PSA after radical prostatectomy

SMMC 14009:   ALLIANCE A031201 Phase III trial of Enzalutamide (NSC # 766085) vs Enzalutamide, Abiraterone and Prednisone for castration resistant metastatic prostate cancer

Presently there are no protocols available at SMMC for the Bladder, Brain, Cervix, Chemoprevention, Colorectal/Anus, Gastric of Gastrosophageal, Ovarian, Lymphoma, Leukemia or Melanoma, or Mulitple Myeloma.  

BECOMING A RESEARCH PARTICIPANT:

Someday, you or a family member may want to take part in a research study. If this happens, the information here may help you make the right decision.

What Is Research?

  • Research is a study that is done to answer a question.
  • Scientists do research because they don’t know for sure what works best to help you. They are working to determine the answer as to what is best.
  • Some other words that describe research are clinical trial, protocol, survey, or experiment.
  • Research is not the same as treatment.

Why Is Research Important?

Research has led to important discoveries that make our lives better. Some examples are:

  • New drugs to treat cancer, diabetes, and other diseases
  • Ultrasound, X-ray machines, and diagnostic tests
  • Vaccines
  • Ways to stop smoking
  • Improved medical procedures

These are some questions that you should ask before you agree to participate in a research study:

  • Why is the research being done?  What question are you trying to answer?
  • What will be done to me as part of the research?
  • How will I benefit from the research?
  • What other options do I have?
  • Could the research hurt me?
  • Have other studies like this one been done?
  • What will the researcher do with my information?
  • Will the research cost me anything?
  • Who pays if I’m unexpectedly injured in the study?
  • How long will the study last?  What do I have to do as far as office visits, medications, medical tests?
  • What happens if I decide to leave the study early?
  • Who should I call if I have a question about the research?

Points to Consider

  • A research study may or may not help you personally.
  • In the future, the results could help others who have a health problem.
  • Taking part in research is voluntary.

Before you decide to become a research volunteer, get the facts:

  • Know what you’re getting into.
  • Ask questions.
  • Learn as much as you can.
  • Know the pros and cons.