Clinical Trials

Clinical trials test the safety and effectiveness of new or modified cancer drugs, new drug doses, unique approaches to surgery or radiation therapy, and varied combinations of treatments. Clinical trials are an integral component for improving the treatment of medical conditions because they lead to higher standards of care.

There are four research phases of a clinical trial:

  • Phase I – The drug is only given to a small number of patients. Researchers look for the best way to give a new treatment. If the drug proves to be safe, the trial proceeds to Phase II.

  • Phase II – The drug undergoes testing to determine its effect on different types of cancers. Researchers also look for ideal dosing ranges and possible side effects.

  • Phase III – If the drug shows activity against the cancer, it is then compared with common or standard therapies. Researchers want to establish if the trial therapy is more beneficial than the standard therapy. The patients who take part in this comparison are randomly chosen to receive either the new treatment or the standard treatment. Those receiving the standard therapy are referred to as the “control group.” The control group receives the best available standard treatment. Phase III studies usually include hundreds of participants around the country.

  • Phase IV – continues the assessment of the safety and effectiveness of cancer therapies that are already FDA approved and available for the general public.

Cape Fear Valley Cancer Center participates in Phase II, III, and IV clinical trials.

Clinical trials provide advances in medicine and science. New cancer treatments must be proven to be safe and effective. Through these scientific studies, researchers are able to conclude which methods of treatment are most successful.

There are many advantages to enrolling in a clinical trial at The Cancer Center. Not only does the participant benefit from a study that may prove to be a superior treatment, but others also benefit from the increased knowledge that the study discloses.

Michelle Gereghty, RN, OCN, is the Research Coordinator at The Cancer Center. Michelle determines if the patient meets all eligibility requirements necessary to participate in a clinical trial. She also provides information on current studies and answers questions regarding the safety and side effects of the treatment.

An Institutional Review Board (IRB) oversees the action plan or protocol related to each clinical trial conducted at The Cancer Center. The IRB is comprised of physicians, medical specialists, nurses, social workers, medical ethicists and patient advocates who have no special interest in any specific trial. IRB members are responsible for reviewing protocols to ensure that patients are not exposed to unethical risks. These boards also ensure that trials are conducted with the full consent of the patient.

Participating in a study is completely voluntary. Clinical trials do require that a participant be able to receive a treatment and submit to monitoring and follow-ups. However, patients who join a study are free to withdraw at any time.

In most cases, patients and the trial sponsors are financially responsible for clinical trial costs. Drugs offered in the study may be supplied by the pharmaceutical company through the National Cancer Institute; however, patients participating in the study may be responsible for routine costs, such as doctor visits, lab tests, scans, x-rays and hospital fees.

Clinical research studies add to our knowledge and progress against cancer. Patients who take part may be among the first to benefit from innovative therapy and as a result, provide useful information, which will aid many others.

Those interested in learning whether they are candidates for one of clinical trials being conducted at The Cancer Center Oncology Research Department at (910) 615-5603.

Trials currently available at the Cape Fear Valley Cancer Center

NSABP B-47: 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.

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 – using Oncotype Dx to determine the Recurrence Score.

The purpose of this study is to find out if the Oncotype DX® Recurrence Score can help decide whether patients should receive chemotherapy or not. This study is being done in patients with lower Recurrence Scores (25 or less).

Amgen Protocol Number: (pegfilgrastim) 20110148 → A Phase 2, randomized, single-blind study to estimate the effect of patient education on reported bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim (Neulasta) - also known as the VINE study: Video Impact on Neulasta Education

In this study, the effect of patient education on reported bone pain in breast cancer patients receiving adjuvant or neoadjuvant chemotherapy and pegfilgrastim will be investigated.