Clinical Research

What are Clinical Trials?

What are the Benefits of Joining a Clinical Trial?

Am I Eligible for a Clinical Trial?

How are Clinical Trials conducted?

Current trials at Hunterdon Regional Cancer Center

Testimonials

 

What are Clinical Trials?

 A clinical trial is a study that helps doctors and researchers find better ways to prevent, treat or diagnose diseases such as cancer. There are several types of cancer clinical trials -- some test new ways to treat cancer; others test new methods of prevention, detection or diagnosis.

 When laboratory research shows that a new treatment method has promise, cancer patients can receive the treatment in carefully controlled trials. These trials can help the researcher evaluate the effectiveness of new drugs and interventions and are essential for studying treatments and possible cures. Often, clinical trials compare a new treatment with a standard approach so that doctors can learn which is more effective. Researchers also look for ways to reduce the side effects of treatment and improve the quality of patients' lives.

 Through Hunterdon Regional Cancer Center's partnership with Philadelphia's Fox Chase Cancer Center, physicians have access to many clinical research trials, which are administered by specially trained staff. The availability of clinical research at Hunterdon Regional Cancer Center allows our patients the ability to receive their treatment in their own community and lessen the burden of travel to distant academic institutions.



What are the Benefits of Joining a Clinical Trial?

 Taking part in a clinical trial allows you to play an active role in your health care and receive excellent medical care. Because a clinical trial must follow a strict protocol, or plan, people in clinical trials are very closely observed. They may have access to new cancer treatments and techniques before they are widely available. Doctors perform clinical trials because they believe the drugs or techniques they’re testing could be more effective or safer than the standard treatments they are using now. Doctors hope the information learned from trials will help future patients.

 

Am I Eligible for a Clinical Trial?

 When planning a clinical trial, researchers decide on eligibility criteria -- characteristics about the people they would like to study. These characteristics generally include how young or old a person must be to join; what type and stage of cancer that person has; what previous treatments the patient has undergone, and other medical problems the person may have. If you think you would like to take part in a clinical trial, one good place to start is by asking your doctor or nurse about the trials available for your cancer.

 

The Hunterdon Regional Cancer Center has two specially trained Registered Nurses with extensive experience in research. They are available to answer questions about current clinical research trials and prevention trials.

 To learn more about available clinical research trials contact:
Kathy Robbins RN, MSN, OCN
Clinical Research Nurse
Hunterdon Regional Cancer Center
2100 Wescott Drive
Flemington, NJ 08822
robbins.kathleen@hunterdonhealthcare.org
908-237-2330 ext. 2
Fax: 908-237-2351

 

If you are considering participation in a clinical trial, here are some questions to ask your doctor:

  • What is the purpose of the clinical trial?
  • What are the pros and cons of participating in a clinical trial?
  • What are my other treatment options?
  • Will there be extra costs because of the trial?
  • How long will the trial last?

How are Clinical Trials conducted?

Clinical Trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.

  • Phase I trials – researchers test a new drug or treatment in a small group of people for the first time. These studies evaluate how a new drug should be given, how often it should be administered and the most effective dose with the fewest and least serious side effects. 
  • Phase II trials – these studies continue to test the safety of the drug and how well it works in a selected tumor type. 
  • Phase III trials – these studies will confirm the new drug effectiveness, observe side effects, compare the new treatment with currently used standard treatments, and collect information that will allow the new drug to be used safely. 
  • Phase IV trials – these studies test the drug or treatment after FDA approval to find out additional information about the treatments risks and benefits and the best way to use it. These studies help doctors understand the long-term safety.

 

Depending on what is being studied, a particular clinical study may involve patients with cancer or people who do not have cancer but are at higher risk than most people for developing it. By participating in a clinical trial, patients may benefit from a new drug, procedure, or symptom-control method while helping scientists evaluate its effectiveness. Participation may also contribute directly to finding better ways to prevent, detect, or treat the disease. Many of today's most effective interventions are the direct result of knowledge gained through clinical research.

Clinical trials are reviewed at a national and local level.  The Institutional Review Board (IRB) at Hunterdon Medical Center is a committee that has reviewed the clinical research studies to help ensure that the rights and welfare of each research participant are protected and that the study will be carried out in an ethical manner. The IRB has many different members, including doctors, nurses, patient advocates, and people from the community.

Current trials at Hunterdon Regional Cancer Center as of 10-26-12)

Current trials offered at Hunterdon Regional Cancer Center include new treatment protocols for breast, gastrointestinal and lung cancers, lymphoma and melanoma.

BREAST PROTOCOLS

  • NSABP B43 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 
  • NSABP B47 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
  • NSABP B49 A Phase III Clinical Trial Comparing the Combination of Docetaxel plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

 

GASTRIC SYSTEM PROTOCOLS

  • RTOG 0848 A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma
  • CALGB 80702 A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer

LUNG PROTOCOLS

E1505 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)

  • E5508 A Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
  • S0819 A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
  • E6505  Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB Non-Squamous Non-Small Cell Lung Cancer after Definitive Chemoradiation

  

LYMPHOMA

  • E2408 A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High-Risk Follicular Lymphoma

  

MELANOMA

  • E1609  A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon Alfa-2b for Resected High-Risk Melanoma
  •  E 3611  A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-α in Advanced Melanoma