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Clinical Research

When laboratory research shows that a new treatment method has promise, cancer patients can receive the treatment in carefully controlled trials. Clinical trials are studies that 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.

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.

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.

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 offered at Hunterdon Regional Cancer Center include new treatment protocols for breast, prostate, gastrointestinal, head and neck cancers, gynecologic, melanoma, bladder, kidney and lung cancers, leukemia and lymphoma.

Featured Protocols (as of 10/26/12)

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

E2108  A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

NSABP B-49 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

NSABP P5 Statin Polyp Prevention Trial in Patients with Resected Colon Cancer

E 7208 A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy

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.

N0949 A Randomized Phase III Trial of mFOLFOX7 or XELOX Plus Bevacizumab Versus 5-Fluorouracil/Leucovorin or Capacitabine Plus Bevacizumab as First-line Treatment in Elderly Patients with Metastiatic Colorectal 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)

E3508 A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab with or without IMC-A12 in Patients with Advanced Non-Squamous, Non-Small Cell Lung Cancer        

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/Paclitexel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

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

PROSTATE PROTOCOLS

E3805 CHARTED – ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

 
Hunterdon Regional Cancer Center has 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 and prevention research contact:

 Rene Falls, RN OCN at (908)237-2330 ext. 2 or falls.rene@hunterdonhealthcare.org

 Lynda Poff, RN OCN at (908) 237-2330 ext.4 or poff.lynda@hunterdonhealthcare.org

For more information on genetic factors and cancer risk contact:

Jackie Hale, APN, AOCN at (908) 237-2330 ext. 1 or hale.jacqueline@hunterdonhealthcare.org

 


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?