May 17 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news) announced today that it has signed an agreement with Pharmacia Corporation to conduct a collaborative study of THALOMID® (thalidomide) in combination with CAMPTOSAR® (irinotecan) and 5-fluorouracil and leucovorin (5-FU/LV). CAMPTOSAR and 5-FU/LV is the only regimen that has demonstrated a survival benefit over 5-FU/LV and is standard of care for first-line treatment of metastatic colorectal cancer. The term metastatic refers to a cancer that has spread to other parts of the body.
Celgene and Pharmacia will initiate a multi-center, randomized, controlled Phase II study evaluating the safety and efficacy of CAMPTOSAR-based therapy in combination with THALOMID in 150 patients with previously untreated metastatic colorectal cancer. An interim analysis will be performed after 75 patients have been treated. If signs of clinical benefit are observed, one of three different doses of THALOMID will be selected and another 75 patients will be enrolled into the study.
As previously announced by Celgene, a study published in the August 12, 2000 issue of The Lancet reported an interim analysis of a pilot study evaluating the combination of THALOMID and CAMPTOSAR for patients with previously untreated metastatic colorectal cancer.
``The initial objective of this new trial will be to examine the potential of THALOMID, CAMPTOSAR and 5-FU/LV for the treatment of previously untreated metastatic colorectal cancer,'' said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer of Celgene Corporation. ``One of the major endpoints of this trial will be to examine the side effect profile of THALOMID and CAMPTOSAR combination therapy.''
Colorectal Cancer
Colorectal cancer is the number two cancer killer of all Americans, second only to lung cancer. Over one million Americans have been diagnosed with colorectal cancer. This year alone, an estimated 135,000 Americans will be diagnosed with colorectal cancer and approximately 57,000 people will die of the disease. Almost 77,000 people each year develop metastatic colorectal cancer that has spread to other parts of the body (57% of patients diagnosed with colorectal cancer have metastatic cancer). The majority of new cases of colorectal cancer are diagnosed in people over the age of 50... |
