A Phase 2 Study of AZD2171 (Cediranib) With Modified FOLFOX6 in Patients With Advanced Biliary Cancers
I. To determine the response rate to AZD2171 (cediranib maleate) and modified folinic
acid-fluorouracil-oxaliplatin-6 regimen (FOLFOX 6) in subjects with advanced biliary
I. To determine overall assessment of toxicity of AZD2171 and modified FOLFOX6. II. To
determine the progression-free survival of subjects with advanced biliary cancers treated
with AZD2171 and modified FOLFOX6.
III. To determine overall survival of subjects with advanced biliary cancers treated with
AZD2171 and modified FOLFOX6.
Patients receive cediranib maleate orally (PO) once daily (QD) on days 1-14 and modified
FOLFOX6 comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2
hours, and fluorouracil IV over 46 hours on day 1. Courses repeat every 14 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 6 months for 2 years, and then annually thereafter.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimation of the response rate of patients with advanced biliary cancers treated with cediranib maleate and modified FOLFOX6 evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Estimated based on the number of responses using a binomial distribution and its confidence intervals will be estimated using Wilson's method. The 95% confidence intervals should be provided.
Up to 3 years
Case Western Reserve University
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Firelands Regional Medical Center||Sandusky, Ohio 44870|
|Case Western Reserve University||Cleveland, Ohio 44106|
|M D Anderson Cancer Center||Houston, Texas 77030|
|Lombardi Comprehensive Cancer Center at Georgetown University||Washington, District of Columbia 20057|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|
|Lake University Ireland Cancer Center||Mentor, Ohio 44060|
|Southwest General Health Center Ireland Cancer Center||Middleburg Heights, Ohio 44130|
|UHHS-Chagrin Highlands Medical Center||Orange Village, Ohio 44122|
|Ireland Cancer Center at Firelands Regional Medical Center||Sandusky, Ohio 44870|
|Ireland Cancer Center Landerbrook Health Center||Mayfield Heights, Ohio 44124|
|UH-Seidman Cancer Center at Saint John Medical Center||Westlake, Ohio 44145|