CLINICAL TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER TO BEGIN AT TCCC
A Phase I/II Clinical Trial of Bortezomib (Velcade) + Pemetrexed (Alimta) in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer

Aptium Oncology Research Network Protocol # 05LUN01 (MPI-X05134)

Trinitas Comprehensive Cancer Center (Trinitas CCC) announced today its participation in a nationwide, multi-center clinical trial for previously treated patients with advanced Non Small Cell Lung Cancer (NSCLC). As part of the Aptium Oncology Research Network, Trinitas CCC is working in partnership with several U.S. cancer centers and principal investigators. Participation in the 05LUN01 study is currently available in NJ through the Trinitas Comprehensive Cancer Center, which is currently one of five medical facilities in the United States accepting volunteers for this Phase I/II study. The study for patients who meet certain criteria focuses on a novel approach for targeting and destroying cancer cells by administering VELCADE (an FDA approved drug developed and provided by Millennium Pharmaceuticals, Inc.), rather than the more traditional chemotherapy approach. Participating in this study is Trinitas Comprehensive Cancer Center (TCCC) in Elizabeth, New Jersey.

VELCADE, (Bortezomib) a proteasome inhibitor* which is FDA approved for second line therapy for multiple myeloma and mantle cell lymphoma will be evaluated in this new clinical trial on previously treated patients with advanced Non Small Cell Lung Cancer (NSCLC). Traditional chemotherapy works by destroying fast growing cancer cells, but also may produce some unwanted side effects that inhibit hair, skin, and mucous membranes. "With only about 50% of lung cancer patients responding positively to traditional platinum based chemotherapy treatment, and with 150,000 deaths annually, lung cancer continues to demand dedicated research into alternative therapies," said Trinitas CCC Principal Investigator Dr. Vincent E. Salerno, who is Board certified in Medical Oncology, Hematology, and Internal Medicine. "This clinical study reflects our intense commitment to develop novel and effective therapies and may offer an option for people with Non Small Cell Lung Cancer."

In order to be enrolled in this clinical trial, patients must meet the following eligibility criteria:

· Must be 18 years of age or older with confirmed NSCLC (histological or cytological).

· Must have unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC and must have received one prior platinum based chemotherapy regimen.

· In part A of this study, patient may have received up to two prior chemotherapy regimens.

· Patient should have a life expectancy of over two months

· Female patient should be either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.

· Male patient must agree to use an acceptable method of contraception for the duration of the study.

For additional information on this clinical trial, please contact Maria Serrano, Clinical Research Manager at 908-994-8539.

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About Trinitas Comprehensive Cancer Center
Trinitas Comprehensive Cancer Center (TCCC) is located in a state-of-the-art 28,000-square-foot, five-story building on the campus of Trinitas Regional Medical Center in Elizabeth, New Jersey. The Center offers the most advanced technology available to cancer patients, including the following "firsts" in the state: the first Trilogy Linear Accelerator for radiation therapy, the first Rapid Arc radiotherapy technology, and the first AccuBoost Image-Guided Breast Irradiation. For more information about cancer care at Trinitas Comprehensive Cancer Center call 908-994-8000.

Posted: May 12, 2008

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