Phase II Study to Assess the Safety and Efficacy of Carboplatin, Paclitaxel and Bevacizumab ± Combretastatin A4 Phosphate (CA4P) Followed by Bevacizumab ± CA4P in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)
Lung cancer has become the leading cause of cancer death in both men and women in the US and
Europe, accounting for 29% of all cancer deaths. Non-Small Cell Lung cancer (NSCLC)
accounts for approximately 80% of all lung cancer cases. Currently, no curative treatment
is available for advanced stages of the disease (stages III and IV), which comprise the
majority of cases. Treatment with the combination of carboplatin and paclitaxel has been
shown to be effective and well tolerated in advanced stage NSCLC. Targeted therapies, such
as bevacizumab, often act synergistically with chemotherapy. Bevacizumab inhibits VEGF,
necessary for endothelial cell proliferation and new blood vessel formation. CA4P targets
existing abnormal vasculature of tumors, impeding tumor blood flow and leading to extensive
tumor cell death as a consequence of oxygen and nutrient deprivation.
This study will compare the effect of CA4P when combined with chemotherapy and bevacizumab
on progression free survival (PFS) to PFS after chemotherapy and bevacizumab alone.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of the combination therapy assessed by analysis of adverse events, physical examination, blood tests, ECGs
Six 21-day cycles
Yes
Jai Balkissoon, MD
Study Director
OXiGENE
United States: Food and Drug Administration
OXC401-216
NCT00653939
March 2008
October 2011
Name | Location |
---|---|
Kentuckiana Cancer Institute | Louisville, Kentucky 40202 |
The Center for Cancer and Hematologic Disease | Cherry Hill, New Jersey 08003 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Bay Area Cancer Research Group, LLC | Concord, California 94520 |
San Juan Oncology Associates | Farmington, New Mexico 87401 |
Northwest Medical Specialties | Tacoma, Washington 98405 |
Lahey Clinic Medical Center | Burlington, Massachusetts 01805 |
Southbay Oncology Hematology | Campbell, California 95008 |
Pacific Coast Hematology and Oncology Medical Group | Fountain Valley, California 92708 |
UCLA Division of Hematology and Oncology | Los Angeles, California 90095 |
The Mark H. Zangmeister Center | Columbus, Ohio 43219 |
Signal Point Clinical Research | Middletown, Ohio 45042 |
Blueridge Cancer Care | Salem, Virginia 24153 |
Mary Babb Randolph Cancer Center-Clinical Trials Unit | Morgantown, West Virginia 26506 |