A Message from Marianne Balay, MS, RN Associate Director, CINJOG

October is National Breast Cancer Awareness Month -  The American Cancer Society estimates 183,000 new cases of breast cancer will be diagnosed in the United States this year with more than 40,000 dying from the disease. In New Jersey alone 6,300 new cases are expected with 1,400 deaths. It is these statistics that researchers at The Cancer Institute of New Jersey (CINJ) hope to have impact on with several important clinical trials.

In honor of Breast Cancer Awareness month, we encourage you to review the following two trials for breast cancer listed in the new CINJOG trial menu released in August. In addition, I would like to add a personal note to everyone to recognize National Breast Cancer Awareness Month by paying attention to when your annual mammogram is due and please remind your loved ones to do the same.

In advanced breast cancer, combinations of chemotherapy drugs to kill cancer cells result in response rates between 40 and 70 percent and complete response rates or clinical remissions are rare. Although there has been progress in prolonging survival in metastatic breast cancer, ultimately the majority of women die from their disease.

Deborah Toppmeyer, MD, is the lead researcher on this clinical study which will examine how patients respond to treatment with a novel combination of three agents, doxil, carboplatin, and the anti-blood vessel (anti-angiogenic) biologic, bevacizumab. This new combination of chemotherapy drugs are targeted at patients who have been diagnosed with previously untreated triple-negative metastatic breast cancer. Triple negative is a type of breast cancer that does not express estrogen or progesterone receptors or HER2 protein. Thus, standard treatments with hormone blocking agents and agents that target HER2 such as tamoxifen and the antibody herceptin, respectively, are ineffective weapons against this subtype of breast cancer. As a result, women with triple negative breast cancer have a shorter survival and identifying better combinations of chemotherapy and novel biologic agents that are effective in this disease is critical.

Antoinette Tan, MD is the PI of a clinical trial that aims to evaluate a new treatment for breast cancer in combination with one that is already approved for other cancers. The new combination is targeted toward treatment of hormone receptor-positive locally advanced cancer
or metastatic breast cancer. Sorafenib is an approved medication by the U.S. Food and Drug Administration (FDA) used to treat certain advanced kidney cancers and liver cancer. It fights the disease by interfering with the ability of cancer cells to grow and divide. There have been studies performed with this drug by itself in patients with metastatic breast cancer, with results showing only a small effect on the tumor. In this study, selected patients will take letrozole and sorafenib by mouth and keep a pill diary for 28 days. At 12 weeks, patients will undergo tests like a CT scan or MRI, which look at the organs in the body, to check on the combined effect on the tumor. The aforementioned drugs for the study will be supplied by Bayer Pharmaceuticals and Novartis Pharmaceuticals.

Lastly, with the holiday season approaching, I'd like to remind everyone to celebrate healthy choices. By choosing healthy foods and increasing our physical activity we can all benefit from a reduction in overall cancer risk and enjoy the season !

Marianne Balay, MS, RN
Associate Director, CINJOG
Phone – 732-235-7150
Mobile – 908-229-9045
Email – balaymt@umdnj.edu

Education
Roche Lectureship at the Annual CINJOG Research Meeting - Tuesday, October 20, 2009 at CINJ. New Frontiers in Metastatic Breast Cancer. Speakers include Antoinette Tan, MD, Deb Toppmeyer, MD from CINJ and Christy Russel, MD from the University of Southern California. Please make every effort to attend to this valuable program. RSVP by visiting the CINJ Nursing Education Web Site or by calling 732-235-8784.

Research Coordinator Forum - Recruitment & promotion strategies for Clinical Trials - Thursday, November 12, 2009 from 10:00am - 1:00pm in CINJ Auditorium A. Arlene Rossi, RN from CINJ- Hamilton and Yasmeen Barber, BA, Clinical Research Coordinator from University Hospital in Newark will speak about successful methods to screen patients into clinical trials. There will also be time provided for discussion and networking with other research coordinators in the CINJOG Network. Register by calling Marlene Salzinger at 732-235-7251 or email at salzinma@umdnj.edu

Basic Clinical Trials Research Course - Mark your calendars and register for the next course on December 10, 2009. Designed for new oncology clinical trials nurses, study coordinators, and data managers, this course provides a basic, comprehensive overview of the conduct of oncology treatment trials according to U.S. Regulations and Good Clinical Practice guidelines. Please encourage all of your new research staff to attend to this valuable program and RSVP to Marlene Salzinger at 732-235-7251 or email at salzinma@umdnj.edu.

Current CINJOG Trials

Additional information on the trials listed below can be found on the CINJ web site and in the CINJOG Summer 2009 Trial Menu.

CINJOG # 030801 (NJ 1508) Modulation of Autophagy with Hydroxychloroquine in Combination with Carboplatin, Paclitaxel and Bevacizumab in Patients with Advanced/Recurrent Non-Small Cell Lung Cancer - A Phase I/II Study (page 83).

CINJOG # 040504 (NJ1105 Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate versus Gemcitabine Alone in Patients with Previously Treated Locally Advanced or Metastatic Breast Cancer (page 7) .

CINJOG # 040608 (NJ 1106) Phase II Trial of Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in Patients with HER2/neu-Overexpressing Advanced or Metastatic Pancreatic Cancer (page 6).

CINJOG # 040702 (NJ 2107) A Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer (page 5).

CINJOG # 040706 (NJ 1107) A Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women with Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer (page 12).

CINJOG # 040803 Phase I/II Study of Weekly Abraxane and RAD001 in Women with Locally Advanced or Metastatic Breast Cancer (page 9)

CINJOG # 040804 (NJ 1108) A Phase I/II Study of Ixabepilone in Combination with the Autophagy Modulator Hydroxychloroquine for the Treatment of Patients with Metastatic Breast Cancer (page 11).

CINJOG # 070806 Autophagy and Anti-Angiogenesis in Metastatic Colorectal Carcinoma: A Phase II trial of Hydroxychloroquine to Augment Effectiveness of XELOX-Bevacizumab(page 42) .

CINJOG # 080804 A Phase II, Multicenter Trial of Genciabine, Carboplatin, and Sorafenib in Chemotherapy-naïve Patients with Advanced/Metastatic Bladder Carcinoma (page 54) .

CINJOG # 080805 (NJ2080) A Phase II Study of Docetaxel and Modulation of Autophagy with Hydroxychloroquine for Metastatic Hormone Refractory Prostate Cancer (page 53).

CINJOG # 080811 A Phase II trial of Atorvastatin and Celecoxib in Patients with Hormone-Dependent Prostate-Specific Antigen Progression after Local Therapy for Prostate Cancer (page 52).

CINJOG # 080803 (NJ1808) Autophagic Cell Death in Patients with Hormone-dependent Prostate-Specific Antigen Progression after Local Therapy for Prostate Cancer (page 51) .

CINJOG # 100101 (NJ1703) A Phase II Trial of Chemosensitization with Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma.