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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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