Clinical Trials
In 2007, CHO committed to starting a clinical trials research program. Commonwealth Hematology-Oncology is a member of the Eastern Cooperative Oncology Group (ECOG). This membership affords us the opportunity to provide clinical research, sponsored by the National Cancer Institute, for our patients at eight of our offices – Dorchester, Haverhill, Lawrence, Newburyport, Quincy, Stoneham, Weymouth and Worcester.
The Commonwealth Hematology-Oncology, P.C. research team includes Melynn Nuite, RN, BS – clinical research manager; Janet Golan, RN – research nurse; Susan Carrozza, RN, MS – research nurse; Angela Waszak, MS – clinical research associate; Margaret Rush, B. Sc. – data and regulatory administrator and James R. Everett, MD – NCI trials principal investigator.
Every effort is made to ensure the research participants’ safety as all research studies are reviewed by an Institutional Review Board (IRB). An IRB, also known as an independent ethics committee (IEC) or ethical review board (ERB), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the human research participants/subjects.
People participate in cancer clinical trials for a variety of reasons: Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Over the past four years, 86 patients have opted to participate in CHO research studies. The National Cancer Institute (NCI) and ClinicalTrials.gov are resources to learn more about clinical trials and to see the multitude of clinical trials that are being conducted throughout the United States of America and beyond.
The studies listed below are the clinical trials that are presently open for enrollment here at Commonwealth Hematology-Oncology, P.C. If you are interested to learn more about the studies listed here please talk with your cancer care provider.
Breast Cancer:
- CALGB 70604: A Randomized, Phase III Study of Standard Dosing vs. Longer Dosing Interval of Zolendronic Acid in [Bone] Metastatic Cancer [CHO PI Dr James Everett]
- GHS 01-114: (Genomic Health Inc.) Impact of the OncoType DX® Assay Recurrence Score® on Adjuvant Therapy Decision making in Early Stage, Estrogen Receptor-positive, Node-negative Breast Carcinomas from Large Group Community Medical Oncology Practices [CHO PI Dr Pedro Sanz-Altimira]
- 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 [CHO PI Dr James Everett]
- SWOG S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less [CHO PI Dr James Everett]
Chronic Myeloid Leukemia (CML):
- CA180-330; SIMPLICITY: (Bristol-Myers Squibb Co.) Studying Interventions for Managing Patients with Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-year Prospective Cohort Study [CHO PI Dr Darren Evanchuk]
Colon Cancer:
- CALGB C80702: A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer [CHO PI Dr James Everett]
Lung Cancer:
- ECOG E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) [CHO PI Dr James Everett]
- G300504: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients with Non-Small Cell Lung Cancer on First Line Platinum Plus a Taxane Chemotherapy
- G300505 : A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients with Non-Small Cell Lung Cancer on First Line Platinum Plus a Non-Taxane Chemotherapy
Multiple Myeloma:
- CALGB 70604: A Randomized, Phase III Study of Standard Dosing vs. Longer Dosing Interval of Zolendronic Acid in [Bone] Metastatic Cancer [CHO PI Dr James Everett]
Prostate Cancer:
- CALGB 70604: A Randomized, Phase III Study of Standard Dosing vs. Longer Dosing Interval of Zolendronic Acid in [Bone] Metastatic Cancer [CHO PI Dr James Everett]
- ECOG E3805: ChemoHormonal Therapy vs. Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer – the CHAARTED Trial [CHO PI Dr James Everett]
SWOG S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
The purpose of this study is to find out if the Oncotype DX® Recurrence Score can help decide whether patients with hormone-responsive breast cancer with 1-3 positive lymph nodes who have a Recurrence Score of 25 or less should receive chemotherapy after surgery.
The Oncotype DX® test is a test that looks at multiple genes related to breast cancer. The combination of the test results produces a score that is useful in guiding treatment choices for patients with both lymph node-negative and lymph node-positive breast cancer. The higher the score is the more likely that the patient’s breast cancer will come back after surgery.
For more information about this test you can look at the following website: http://www.oncotypedx.com/en-S/Breast/PatientCaregiver/OncoOverview.aspx
If the results of the study show that the benefit for getting chemotherapy is dependent on the Recurrence Score, the study should be able to identify a Recurrence Score level where chemotherapy should be considered (and a Recurrence score level where chemotherapy my not be needed.
For more information about this study you can look at the following website: http://www.clinicaltrials.gov/ct2/show/NCT01272037?term+S1007&rank=1
S1007 RxPonder Randomization Fact Sheet
CALGB 70604: A Randomized, Phase III Study of Standard Dosing vs. Longer Dosing Interval of Zolendronic Acid in [Bone] Metastatic Cancer
The purpose of this study is to compare the effects (good, bad or not difference) of less frequent treatment (every 12 weeks) with zoledronic acid (Zometa) compared to standard treatment (every 4 weeks) with zoledronic acid.
Zoledronic acid decreases the risk of certain bone related complications in people with breast cancer, prostate cancer, or multiple myeloma AFTER the cancer has spread to the bones and continues to grow ever with the standard anti-cancer therapy.
This research is being done to find out if less frequent dosing will be as good as the standard dosing at preventing bone complications due to cancer. We also hope to find out whether the less frequent dosing for zoledronic acid is safer than the more frequent dosing.
For more information about this study you can look at the following website: http://clinicaltrials.gov/ct2/show/NCT00869206?type=Intr&cond=metastatic+cancer&intr=zoledronic+acid&rank=6
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
The purpose of this stud is to find out if adding a drug called trastuzumab to breast radiation therapy will be more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in patients with HER2-positive ductal carcinoma in situ (DCIS) who have undergone lumpectomy. DCIS is a very early stage of breast cancer and radiation therapy, which uses high-energy x-rays to kill tumor cells, is the standard treatment. The drug trastuzumab targets breast cancers that make too much of a protein called HER2. HER2 can cause cells to receive extra growth signals and this can turn a normal cell into a cancer cell and can cause cancer cells to grow faster. Trastuzumab has been shown to block the HER2 protein and to slow down or stop the growth of HER2-positive “invasive” breast cancers.
For more information about this study you can look at the following website: http://clinicaltrials.gov/ct2/show/NCT00769379?term=NSABP+B43&rank=1
CALGB C80702: A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer
This study is being done to evaluate the effects (good and bad) of an oral drug called celecoxib wen given in combination with 6 or 12 treatments of FOLFOX (a combination of the chemotherapy drugs 5-fluorouracil, leucovorin and oxaliplatin). FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).
Celecoxib is approved by the FDA to treat arthritis. It is also approved to help prevent colon polyps in families with a genetic risk for colon cancer. The addition of celecoxib to FOLFOX chemotherapy is considered investigational. One of the purposes of this study is to determine if giving patients celecoxib (by mouth) and chemotherapy decreases the risk of colon cancer recurrence. In this study you will be assigned to receive celecoxib or placebo (‘sugar’) capsules.
This study will also look at whether receiving FOLFOX chemotherapy for 6 treatments (over 12 weeks) is a good as 12 treatments (over 24 weeks) in preventing recurrence of colon cancer. Currently, the standard of care for stage III colon cancer is 12 treatments (over 24 weeks) with FOLFOX. If you participate in this study, you will be randomly assigned to the group receiving 6 treatments OR the group receiving 12 treatments of FOLFOX.
Brochure: Patient Guide to the Clear Colon Trial
For more information about this study you can look at the following website: http://clinicaltrials.gov/ct2/show/NCT01150045?term=CALGB+80702&rank=1
ECOG E3805: ChemoHormonal Therapy vs. Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer – the CHAARTED Trial
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 lower 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.
For more information about this study you can look at the following website: http://clinicaltrials.gov/ct2/show/NCT00309985?term=ECOG+3805&rank=2
ECOG E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients with Completely Resected Stage IB-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.
For more information about this study you can look at the following website: ttp://clinicaltrials.gov/ct2/show/NCT00324805?term=ECOG+1505&rank=1
G300504 : A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients with Non-Small Cell Lung Cancer on First Line Platinum Plus a Taxane Chemotherapy
This study is being conducted at the Lawrence, MA office of Commonwealth Hematology-Oncology, P.C. The principal investigator of this study at Commonwealth Hematology-Oncology, P.C. is Pedro M. Sanz-Altamira, MD, PhD
The purpose of this study is to find out if an investigational drug called GTx-024 can help people with non-small cell lung cancer receiving first line chemotherapy increase physical function and maintain or gain muscle.
During this study participants will have 10 scheduled study visits. Some of these visits will be combined with your regular cancer care visits. In this study participants will have to take one study pill a day for about 5 months. Neither you nor your insurance company will have to pay for the study medication. Study participants will be paid for completing research visits.
To learn more about this study please go to the following web site:
http://clinicaltrials.gov/ct2/show/NCT01355484?term=GTx&rank=5
G300505 : A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients with Non-Small Cell Lung Cancer on First Line Platinum Plus a Non-Taxane Chemotherapy
This study is being conducted at the Lawrence, MA office of Commonwealth Hematology-Oncology, P.C. The principal investigator of this study at Commonwealth Hematology-Oncology, P.C. is Pedro M. Sanz-Altamira, MD, PhD
The purpose of this study is to find out if an investigational drug called GTx-024 can help people with non-small cell lung cancer receiving first line chemotherapy increase physical function and maintain or gain muscle.
During this study participants will have 10 scheduled study visits. Some of these visits will be combined with your regular cancer care visits. In this study participants will have to take one study pill a day for about 5 months. Neither you nor your insurance company will have to pay for the study medication. Study participants will be paid for completing research visits.
To learn more about this study please go to the following web site:
http://clinicaltrials.gov/ct2/show/NCT01355497?term=Gtx&rank=4
GHS 01-114: (Genomic Health Inc.) Impact of the OncoType DX® Assay Recurrence Score® on Adjuvant Therapy Decision making in Early Stage, Estrogen Receptor-positive, Node-negative Breast Carcinomas from Large Group Community Medical Oncology Practices
The purpose of this study is to better understand how physician-decision-making regarding adjuvant therapy is impacted by the results of the Oncotype DX® assay.
Study participants (female and male) will have Oncotype DX® testing done. The study doctor will complete a questionnaire before and after the Oncotype DX® testing is done. In this study you will not get any study medicine.
For more information about the Oncotype DX® test, you can look at the following website:
http://www.oncotypedx.com/en-US/Breast/PatientCaregiver/OncoOverview.aspx
CA180-330; SIMPLICITY: (Bristol-Myers Squibb Co.) Studying Interventions for Managing Patients with Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-year Prospective Cohort Study
The purpose of this study is to better understand the use of the tyrosine kinase inhibitors (TKIs) dasatinib, imatinib, and nilotinib in patients newly diagnosed with CML and their quality of life in a real-world setting.
Participants will get their usual CML care and treatments during this observational study. During this study participants will be asked to complete questionnaires at several visits. There are no experimental medicines that will be used in this study.
For more information about this study you can look at the following website:
http://clinicaltrials.gov/ct2/show/NCT01244750?term=Simplicity&type=Obsr&cond=CML&rank=1