A Phase 1-2, Multicenter, Open-Label Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With Weekly Paclitaxel in Patients With Advanced Breast Cancer
Breast cancer is the most common cancer in women in the United States, the second most
common cause of cancer death, and the main cause of death in women ages 45 to 55. In 2006,
212,920 American women will be diagnosed with breast cancer, and 40,970 will die from this
disease.[1]. Fewer than 10 percent of women present with metastatic disease at the time of
diagnosis. However, the majority of women who relapse after initial definitive therapy for
early stage or locally advanced disease will do so with disseminated metastatic disease
rather than an isolated local recurrence. Treatment for metastatic disease is palliative in
intent and will usually involve hormone therapy and/or chemotherapy with or without
trastuzumab. Active chemotherapy agents include anthracyclines, taxanes, vinorelbine,
alkylating agents and antimetabolites. Taxanes have become the cornerstone of first-line
treatment for metastatic breast cancer. Weekly doses of paclitaxel can be administered
continuously for several weeks with a remarkable lack of myelosuppression [2]. Weekly
paclitaxel (80 mg/m2) was directly compared to every three-week therapy (175 mg/m2) in 585
women with metastatic breast cancer. Weekly therapy was associated with a significantly
higher response rate (40 versus 28 percent) and longer TTP (nine versus five months), but
similar overall survival and worse neurotoxicity [3]. Since patients with metastatic breast
cancer are unlikely to be cured of their disease [4], they should be considered candidates
for a clinical trial.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the recommended dose of AEG35156 when used in combination with weekly paclitaxel and at the dose enhance the clinical benefit rate (CBR) of paclitaxel in patients with advanced breast cancer.
2 years
No
David M Loesch, MD
Principal Investigator
Central Indiana Cancer Centers
United States: Food and Drug Administration
AEG35156-202
NCT00558545
November 2007
May 2009
Name | Location |
---|---|
Virginia Oncology Associates | Newport News, Virginia 23606 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Tyler Cancer Center | Tyler, Texas 75702 |
Cancer Centers of Florida, P.A. | Orlando, Florida |
Central indiana Cancer Center | Indianapolis, Indiana 46227 |
Sammons Cancer Center | Dallas, Texas |
Dayton Oncology & Hematology, P.A. | Kettering, Ohio 45409 |
New York Oncology & Hematology P. C., Albany Cancer Center | Albany, New York 12206 |
Northwest Cancer Specialists, P. C. | Vancouver, Washington 98684 |