Peninsula Cancer Institute ~ Clinical Trials


Williamsburg (757) 345-5724 Newport News (757) 534-5555 Gloucester (804) 693-9037

Clinical Trials
Mission Statement Peninsula Cancer Institute has established a program to provide our patients access to the latest clinical trials for cancer prevention and treatment. Our goal is to provide supportive care during treatment and help facilitate each patient´s decision on treatment options. Those individuals who participate in clinical trials are the heroes that make a difference in improving medical care for patients with cancer. Research is the only way of improving the treatments for cancer and giving people with cancer a better quality of life.
Clinical research into new and more effective types of chemotherapy is ongoing. If early studies suggest that a new treatment may be both safe and effective, further trials are carried out to find out whether it is better than existing treatments or has extra benefit when given together with these treatments. These trials compare the new treatment to the current best standard treatments. Clinical trials are monitored by the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to insure patient safety and that clinical trial guidelines are followed. Each clinical trial has an action plan, which is the protocol that explains how it will work. Each study has a primary physician, Principal Investigator (PI), who oversees the study. Every study is approved by an institutional review board (IRB), which includes laymen, clergy, and health professionals who review the protocol to be sure that the research will not expose the patients to significant risk. Each study enrolls people who are alike in key ways. Eligibility criteria differ from study to study, depending on the research purpose. Eligibility criteria are an important principle of medical research that helps produce reliable results.
Cancer clinical trials include research at three different phases:

Clinical Trials

Mission Statement

Peninsula Cancer Institute has established a program to provide our patients access to the latest clinical trials for cancer prevention and treatment. Our goal is to provide supportive care during treatment and help facilitate each patient´s decision on treatment options. Those individuals who participate in clinical trials are the heroes that make a difference in improving medical care for patients with cancer. Research is the only way of improving the treatments for cancer and giving people with cancer a better quality of life.

Clinical research into new and more effective types of chemotherapy is ongoing. If early studies suggest that a new treatment may be both safe and effective, further trials are carried out to find out whether it is better than existing treatments or has extra benefit when given together with these treatments. These trials compare the new treatment to the current best standard treatments.

Clinical trials are monitored by the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to insure patient safety and that clinical trial guidelines are followed. Each clinical trial has an action plan, which is the protocol that explains how it will work. Each study has a primary physician, Principal Investigator (PI), who oversees the study. Every study is approved by an institutional review board (IRB), which includes laymen, clergy, and health professionals who review the protocol to be sure that the research will not expose the patients to significant risk. Each study enrolls people who are alike in key ways. Eligibility criteria differ from study to study, depending on the research purpose. Eligibility criteria are an important principle of medical research that helps produce reliable results.

Cancer clinical trials include research at three different phases:

	Phase I trials are the first step in testing a new treatment in human beings. In these studies, researchers look for the best way to give a new treatment (e.g. by mouth? IV? Dose?). They find out if and how the treatment can be given safely and watch for harmful side effects. Phase I include only limited numbers of patients.
	Phase II trials focus on learning whether the new treatment has anti-cancer effects (e.g. does it shrink tumors?). As in Phase I, only a small number of people take part because of the risks.
	Phase III trials compare the results from taking the new treatment with results from taking standard treatment. Phase III trials may include hundreds of people around the country.
Clinical trials play a key role in assessing how useful a new treatment might become. Clinical trials need to be carried out with extreme care and thoroughness. Often there is a lot of publicity in the newspaper and on television when a new drug is discovered. Unfortunately there are huge gaps between the time a new treatment is discovered and when it´s true value is established. Once the value of the treatment is established through the clinical trials process, it becomes one of our standard treatments. If you have been offered the opportunity to participate in a clinical trial, there can be many benefits to your participation. You will be carefully monitored during and after the study and you will be helping to improve knowledge about cancer and the development of a new treatment. It is important to bear in mind that some treatments which look promising at first are often found later not to be as good as existing treatments, or have side effects that outweigh the benefits.

PCI Active Clinical Trials
BREAST ECOG E5103 (Adjuvant) A double-blind Phase III trial of Dose Dense Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in patients with lymph node positive and high risk lymph node negative breast cancer. VIRGO (AVF4349n) (Registry) An observational study of treatment patterns and safety outcomes for metastatic or locally recurrent breast cancer. Wyeth 3144A2-3004 Newport News/Wsbg ONLY A randomized, double-blind, placebo-controlled trial of Neratinib (NKI-272) after Trastuzumab in women with early-stage HER-2/NEU overexpressed/amplified breast cancer. SCRI BRE 145 (Adjuvant) A randomized trial of Ixempra vs. Taxol in adjuvant therapy of triple negative breast cancer. NSABP B-43 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. SCRI BRE 126 (Metastatic) A Phase II trial of Panitumumab, Gemcitabine and Carboplatin in triple-negative metastatic breast cancer. GENITOURINARY *SCRI GU 43* (Metastatic 2nd Line) A Phase II trial of high-dose Bevacizumab in the treatment of patients with advanced clear cell renal carcinoma. *OGX-011-10* A randomized, placebo-controlled, double-blind, Phase III study evaluating the clinical benefit of adding Custersin to Docetaxel treatment/Prednisone as an option for second-line therapy in men with castrate resistant prostate cancer. *ECOG E2805* “ASSURE” adjuvant Sorafenib or Sunitinib for unfavorable renal carcinoma. COLON ECOG E5202 A randomized, Phase II study comparing 5-FU, Leucovorin and Oxaliplatin vs 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in patients with stage II colon cancer at high risk for recurrence to determine prospectively the prognostic value of molecular markers. GIST reGISTry An observational database established by Novartis Corp. to obtain data on variations in current diagnostic and therapeutic management for patients with GIST in a variety of practice settings.	GYNECOLOGIC *MORAb-003-004* A randomized, double-blind, placebo-controlled, Phase III study to assess the efficacy and safety of weekly Farletuzumab (MORAb-003) in combination with Carboplatin and Taxane in subjects with platinum-sensitive ovarian cancer in first relapse. SCRI GYN19 A randomized, Phase II study of Paclitaxel/Carboplatin with or without Sorafenib in the first line treatment of patients with stage III/IV epithelial ovarian cancer. LUNG SCRI LUN142 (Adjuvant) A randomized, Phase II trial of adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib versus chemotherapy alone in patients with resected non-small cell lung cancer. Amgen 20070782 A randomized, double-blind, placebo-controlled study to evaluate the long-term safety and efficacy of Darbepoetin Alfa administered at 500 µg once every 3 weeks in Anemic subjects with advanced stage non-small cell lung cancer receiving multi-cycle chemotherapy. SCRI LUN 183 A Phase II trial of Carboplatin, Pemetrexed, and Panitumumab in patients with advanced non-squamous K-ras wild type non-small cell lung cancer. MELANOMA SCRI MEL 19 (Metastatic) A Phase II study of Everolimus in combination with Paclitaxel and Carboplatin in patients with metastatic melanoma. BMS CA184-045 NEW A multicenter treatment protocol for expanded access use of Ipilimumab (BMS-734016) monotherapy in subjects with unresectable stage III or stage IV melanoma MULTIPLE MYELOMA SCRI MM 23 A Phase II study for the evaluation of Bendamustine, Bortezomib, and Dexamethasone (BBD) in the first line treatment of multiple myeloma. UNKNOWN PRIMARY SCRI UNKPRI 21 NEW An open-label randomized phase II trial of Belinostat (PXD101) in combination with Carboplatin and Paclitaxel (BelCaP) compared to Carboplatin and Paclitaxel in patients with previously untreated carcinoma of unknown primary. Effective August 10, 2010
For further information please contact our Research Department at (757) 534-5565.
The following are considered trusted web sites to find further information on clinical trials National Cancer Institute ~ U.S. National Institutes of Health U.S. Food and Drug Administration Cancer Care TrialCheck
Questions to ask your medical team before agreeing to take part in a clinical trial
Why is the clinical trial being done? How will it help me? What kinds of tests and treatments are parts of the trial? How could the clinical trial change what I do every day? What will happen to my cancer with or without this treatment? What treatments could I get if I don´t take part in the clinical trial? What are possible short and long term side effects for me and my family to think about? How do the risks and side effects of the standard treatment compare with the new treatment? How long will the clinical trial last? Will I have to stay in the hospital during the clinical trial? If so, how often and for how long? Will I have check-ups after the clinical trial? How long do I have to make up my mind about joining this trial? Will participation cost me any money?