Peninsula Cancer Institute ~ Clinical Trials

PENINSULA CANCER INSTITUTE

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

LUNG

PR-104-2001 A phase II, multi-center, open-label, trial of PR-104 in treatment naive and sensitive-relapse small cell lung cancer.

APRICOT-L A randomized, double-blind, placebo-controlled multicenter phase II study of the efficacy and safety of Apricoxib in combination with Erlotinib in non-small cell lung cancer patients.

SCRI LUN142 A randomized, phase II trial of adjuvant Carboplatin, Docetaxel, Bevacizumab, and Erlotinib versus chemotherapy alone in patients with resected non-small cell lung cancer.

AVF3995g A placebo-controlled, double-blind, multicenter, randomized, phase II study of Bevacizumab in previously untreated extensive stage small cell lung cancer.

COLORECTAL

SCRI GI 65 A pilot study of adjuvant therapy with Bevacizumab (Avastin) in combination with 5-FU and radiation in patients with stage II and III rectal cancer.

AVF3991n (ARIES) An observational Study of Avastin in combination with chemotherapy for treatment of metastatic or locally advanced and unresectable colorectal cancer, locally advanced or metastatic non-small cell lung (excluding squamous cell histology)

MULTIPLE MELANOMA

UPFRONT Randomized phase 3b study of three regimens in subjects with previously untreated multiple myeloma who are not considered candidates for high-dose chemo or autologous stem cell transplant.

Z-MARK Bone marker directed dosing of ZOMETA for the prevention of skeletal complications in patients with advanced multiple myeloma.

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.

ENDOMETRIAL

A randomized, phase III trial of Doxorubicin/ Cisplatin/ Paclitaxel and GCSF vs. Carboplatin / Paclitaxel in patients with stage III and IV or recurrent endometrial cancer.

PROSTATE

CALGB 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.

BREAST

ION 06-031 A phase II study of Gemcitabine and Bevacizumab as first –line treatment in HER2 negative, locally recurrent or metastatic breast cancer previously treated with Taxanes

ECOG E5103 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.

ECOG E1105 A randomized phase III double-blind placebo-controlled trial or first-line chemotherapy and Trastuzumab with or without Bevacizumab for patients with HER2/NEU over-expressing metastatic breast cancer.

APRICOT-B A randomized, double-blind, placebo-controlled, multicenter, phase II study of the efficacy and safety of Apricoxib in combination with Lapatinib and Capecitabine in the treatment of patients with HER2/Neu+ breast cancer who have failed Trastuzumab, an Anthracycline and a Taxane.

BMS CA 163-131 A randomized, phase II study to evaluate the combinations of Ixabepilone plus Capecitabine or Docetaxel plus Capecitabine in the treatment of metastatic breast cancer.

SWOG S0307 A phase III trial of Bisphosphonates as adjuvant therapy for primary breast cancer.

MDS/HEMATOLOGIC

AVIDA Vidaza patient registry. This is an observational study evaluating patients starting Vidaza. Open to hematological malignancies including MDS and myeloma.

MORE Registry A prospective, non-interventional multicenter registry in iron overloaded lower-risk Myelodysplastic patients.

OVARIAN

206 OC 202 (Dr. Irvin) A Phase I/II, open label, adaptive, randomized study of Liposomal Doxorubicin with or without M200 (Volociximab) for the treatment of subjects with advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer that have relapsed after prior therapy with a platinum / taxane based chemotherapy.

GOG 0218 (Dr. Irvin) A phase III trial of Carboplatin and Paclitaxel plus placebo vs. Carboplatin and Paclitaxel plus concurrent Bevacizumab followed by placebo, vs. Carboplatin and Paclitaxel plus concurrent and extended Bevacizumab, in women with newly diagnosed, previously untreated, stage III (Suboptimal) and all stage IV, epithelial ovarian or peritoneal cancer.

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 Trial Check
	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?
Updated August 11, 2008