Clinical Research at Commonwealth Hematology-Oncology, PC
INTRODUCTION
While CHO has had a long history of participation in clinical research, in 2007 we introduced an exciting new program in our practices. With the aim of giving our patients improved access to the latest in treatment options, CHO is now conducting clinical trials as part of the National Cancer Institute’s (NCI) CICRS program (Cancer Trials Support Unit, Independent Clinical Research Site program). Since its inception in 2002, CICRS doctors around the country have enrolled more than 800 patients into clinical trials through this innovative program. Dr. Walt Kagan, president of CHO, comments, "This is very exciting and significant because it gives us immediate access to the newest trials, which is how we learn that one drug is more effective than an existing one." Initially, most of the studies that CHO undertakes will be Phase III trials - those that compare new medicines to existing, standard, state-of-the-art treatments.Dr. Susan Sajer, of our Concord office, spearheads this program for CHO. Dr. Sajer graduated from Jefferson Medical College in 1985 and completed her Hematology-Oncology fellowship at the New England Medical Center in 1991. She is an Assistant Professor of Medicine at Tufts University School of Medicine and has been the principal investigator for cancer clinical trials at Emerson Hospital since 1996. Dr. Sajer says, "Clinical trials offer hope for the future. Eligible patients can participate in a study comparing standard treatment to a new treatment. If the new treatment proves to be more effective and less toxic, a new standard of care is established."
Started in early October 2007, clinical trials are available to our patients in our Lawrence, Leominster, Weymouth, and Worcester offices. As we expand our research activities, more clinical trials will be offered in more locations.
To learn more about clinical trials, we encourage you to talk to your CHO physician or contact your local research nurse at one of the numbers below:
- Janet Golan, BSN, RN, CHO Worcester (508)-754-2273
- Carolyn Gustason, BSN, RN, OCN, CHO Lawrence (978)-946-8230
- Laurie Halloran, RN, BSN, OCN, CHO Quincy (617)-479-3550
- Jane Kelso, BSN, RN, CHO Weymouth (781)-340-0735
- Victoria Patterson, BSN, RN CHO Stoneham, (781)-279-0196
- Lesley Strathdee, RN, CHO Concord (978)-287-3436
CURRENT CHO CLINICAL TRIALS:
Protocols currently open at CHO with link to NCI Clinical Trials (PDQ) web site for additional protocol information:
| DISEASE SITE | STUDY ID NUMBER | STUDY TITLE | INFORMATION |
| Breast | NSABP B-42 |
A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer | The main purpose of the study is to learn whether or not continuing hormonal therapy with an AI called letrozole for 5 additional years after already taking 5 years of hormonal therapy (which included an AI) can further reduce the chance of breast cancer returning. Another reason for doing this study is to find out whether or not taking the drug Letrozole after taking 5 years of hormonal therapy that included letrozole (or other AI) causes more thinning of your bones (osteoporosis) which can cause your bones to break more easily. We also want to find out if letrozole increases the chance of heart attack, stroke, and other problems with blood vessels called arteries. http://www.cancer.gov/search/ViewClinicalTrials.aspx? cdrid=502263&version=patient&protocolsearchid=3744158 |
| Breast | NSABP B-42 (Registration Program) |
Registration Program to Provide Up to Three Years of Letrozole to Postmenopausal Women with Hormone Receptor Positive Breast Cancer Who Have Received at Least Two Years of Initial Adjuvant Hormonal Therapy | The main purpose of this program is to increase the number of postmenopausal women who have received the hormonal therapy drug letrozole as part of their adjuvant hormonal therapy for breast cancer treatment. NSABP is offering this program so that we can have a larger group of women participating in the main study, NSABP B-42, who have received letrozole as part of their initial adjuvant hormonal therapy. The women who complete their initial adjuvant hormonal therapy in this program will then be asked to take part in the B-42 research study. The main purpose of the B-42 research study is described above. http://www.cancer.gov/search/ViewClinicalTrials.aspx? cdrid=502263&version=patient&protocolsearchid=3744158 |
| Breast | PACCT -1 The TAILORx Trial |
Program for the Assessment of Clinical Cancer Tests (PACCT-1):Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial | The majority of women with early-stage breast cancer are advised to receive chemotherapy in addition to radiation and hormonal therapy, yet research has not demonstrated that chemotherapy benefits all of them equally. This study will examine whether genes that are frequently associated with risk of recurrence for women with breast cancer, that is estrogen receptor positive and/or progesterone receptor positive and that has not spread to the axillary lymph nodes, can be used to assign patients to the most appropriate and effective treatment. TAILORx seeks to incorporate a molecular profiling test called Oncotype DX, which examines many genes simultaneously, into clinical decision making and thus spare women unnecessary treatment if chemotherapy is not likely to be of substantial benefit. This is one of the first trials to examine a methodology for personalizing cancer treatment. Another objective is to create a tissue and blood specimen bank and to collect follow-up information regarding the health status of all women who participate in the study. This will allow researchers, in the future, to evaluate new diagnostic tests that may predict benefits or side effects from certain treatments, as they develop. http://www.cancer.gov/search/ViewClinicalTrials.aspx? cdrid=472066&version=patient&protocolsearchid=4220961 |
| Breast | SWOG S0307 |
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer | Your bones are constantly being made and broken down by your body. Some cancers, including breast cancer, may change this process and even alter the strength of your bones. This can cause a number of problems, such as bone pain, fractures, and the release of too much calcium into the bloodstream. "Bisphosphonates" are a group of drugs that work by attaching themselves to bone and slowing down the rate of bone change. They have strong effects on the bones and have been shown to strengthen the bones in many patients who take them.
This study is investigational and is being done to find out if adding a bisphosphonate to hormonal therapy or chemotherapy will help prevent cancer from spreading to the bones or other parts of the body. The bisphosphonates used in this study are Clodronate (Bonefos®) and Ibandronate (Bondronat®), which are not commercially available in the USA, and Zoledronic Acid (Zometa®), which is an FDA-approved prescription drug used to treat cancers, including breast‚ lung, and prostate cancer that have spread to the bones. http://www.cancer.gov/search/ViewClinicalTrials.aspx? cdrid=437061&version=patient&protocolsearchid=4336522 |
| Colon or Rectum | CALGB/SWOG 80405 |
A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, Or Cetuximab (C225), Or With The Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum | This study is being done to evaluate the effects of different regimens of chemotherapy. There are two common combinations of chemotherapy drugs used to treat this type of cancer: One uses 5-fluorouracil (also called 5-FU), leucovorin, and oxaliplatin, and is also called “FOLFOX;” the other combination uses 5-FU, leucovorin, and irinotecan; this combination is also called “FOLFIRI.” The FDA has approved the use of a drug called bevacizumab (or Avastin) in combination with these chemotherapy regimens. Bevacizumab plus either of these chemotherapy regimens is considered the standard of care for most patients.
Cetuximab (or Erbitux) is an antibody that targets and blocks a specific part of the cancer tumor that is believed to encourage tumor growth. Cetuximab is approved by the FDA for the treatment of colorectal cancer in patients who have developed progressive cancer following the use of irinotecan. The purpose of this study is to determine whether one of the following two combinations — cetuximab plus chemotherapy, or cetuximab plus bevacizumab plus chemotherapy — is better than than the combination of bevacizumab with chemotherapy. |
| Colon | ECOG E 5202 |
A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 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 | When cancer is found in the colon and extends through the wall of the colon, but not in the lymph nodes or other organs, it is considered stage II colon cancer. The study will determine whether specific biological features (often called markers or tumor markers) seen in tests done on a tumor (found in the colon) can be used to predict recurrence of tumors in patients with stage II colon cancer.
We will also compare the effects (good and bad) of a combination of chemotherapy drugs, when given with and without a new drug, bevacizumab, on patients with stage II colon cancer at high-risk for recurrence. The chemotherapy drugs given in this study are 5-fluorouracil (5-FU), leucovorin and oxaliplatin. We want to see if adding bevacizumab to the other cancer-fighting agents is better for treating colon cancer patients, who may be at increased risk for recurrence based on the markers shown in their tumor. We also want to see if adding bevacizumab will help prevent the cancer from coming back.
|
| Lung | ECOG E 1505 |
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>4 cm) – IIIA Non-Small Cell Lung Cancer (NSCLC) | This research is being done because even with the most aggressive after-surgery treatment with chemotherapy, many people still have the lung cancer recur (come back).
The purpose of this study is to determine if adding the new drug bevacizumab to chemotherapy improves the chance for cure for patients who have had surgery for the removal of the lung cancer. We will compare the effects (good and bad) of adding bevacizumab to chemotherapy with standard chemotherapy alone on you and your lung cancer to see which is better at preventing the cancer from coming back.
|
| Prostate | ECOG E 3805 |
CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer | The purpose of this study is to determine whether giving docetaxel chemotherapy, at the time you are starting hormonal therapy and when the hormonal therapy is no longer working, is more effective than giving it only at the time the hormonal therapy is no longer working. Hormonal therapy refers to drugs or surgical procedures used to lower your testosterone. In most patients this puts prostate cancer into remission, as testosterone is like a fuel for the cancer. Hormonal therapy on its own is the standard of care for your cancer. Normally chemotherapy is reserved for when a patient's cancer starts to grow again despite having a low testosterone level. In this study you will either get docetaxel when you start your hormonal therapy or only when/if your cancer grows even with a low testosterone level. If you have chemotherapy when you start hormones for the first time, you may also get chemotherapy when/if your cancer grows back with a low testosterone level.
This trial will let us know which approach is more effective in treating your disease. |
Additional information is available in the following brochures and selected web sites:
BROCHURES
Taking Part in Cancer Research Studies.
This booklet from the National Cancer Institute defines clinical trials, discusses what patients might expect if they participate in a trial,
and presents issues to consider when deciding whether or not to participate.
La participación en los estudios clínicos: Lo que los pacientes de cáncer deben saber.
Este folleto está dirigido a las personas con cáncer, sus familias y demás personas que se preocupan por ellas.
If You Have Cancer and Medicare...You Should Know About Clinical Trials.
This booklet from the National Cancer Institute explains the basics of clinical trials plus information on Medicare coverage.
WEB SITES
- http://www.cancer.gov/clinicaltrials/learning/insurance-coverage
Even if you have health insurance, it may not cover all of the patient care costs that may be involved. This web site offers comprehensive information about you, your insurance coverage, clinical trials, and it presents strategies to deal with cost and coverage barriers. In addition, you can talk to your physician or research nurse about this aspect of clinical trials. - http://www.cancertrialshelp.org/
This easy-to-navigate web page offers links to a host of web pages and enables you to easily access answers to specific questions that you may have. - http://www.fda.gov/oashi/clinicaltrials/default.htm
The Food & Drug Administration web site has basic questions and answers about clinical trials for patients in both English and Spanish (en Español). It also includes information on the regulations that govern clinical research in the U.S.A. together with links to the sites listed here and some others that you might find useful. - http://www.nlm.nih.gov/medlineplus/tutorials/cancerclinicaltrials/htm/index.htm
This is an interactive patient education tutorial about clinical trials. The link to this site is also available on the FDA web site page. - http://www.nlm.nih.gov/medlineplus/spanish/tutorials/cancerclinicaltrialsspanish/htm/index.htm
Este es un curso interactivo de la educación del paciente acerca de los ensayos clínicos. El link a este sitio también está disponible en el sitio web de la FDA. - https://www.ctsu.org/Patients_Page.asp
This web site, maintained by the Clinical Trials Support Unit, publishes the list of active trials, most of which can be made available to our patients at CHO. The site also contains a "Resource" area with both general and clinical trial resource and information links available. - http://www.cancer.org/clinicaltrials
This American Cancer Society web site has lots of useful information. It includes explanations of the different types of clinical trials as well as links to relevant web sites. The information in this web site is user friendly and is clearly and methodically presented. - http://www.cancer.org/docroot/ETO/content/ETO_6_1X_Clinical_Trials_Matching_Service.asp
This is a link to the American Cancer Society Clinical Trials Matching Service where individuals may register and learn about disease and stage-specific clinical trials. - http://www.cancer.gov/clinicaltrials
In this web site, the National Cancer Institute lists the more than 5000 clinical trials that are now accepting patients nationwide together with summaries of recently released results from cancer trials. The site also includes clinical research educational materials for patients.
