Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers
Adult Primary Cholangiocellular Carcinoma
Advanced Adult Primary Liver Cancer
Cholangiocarcinoma of the Extrahepatic Bile Duct
Cholangiocarcinoma of the Gallbladder
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Drug: cediranib maleate
Drug: leucovorin calcium
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of AZD2171 (Cediranib) With Modified FOLFOX6 in Patients With Advanced Biliary Cancers|
- 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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]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.
- Tabulation of the toxicity profile of the combination therapy [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]Number of patients that experience each >/= grade 3 treatment related toxicities
- Estimation of the time to disease progression evaluated using the RECIST v1.1 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Kaplan-Meier method will be used.
- Estimation of overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Kaplan-Meier method will be used.
|Study Start Date:||October 2010|
|Study Completion Date:||February 2015|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cediranib maleate and modified FOLFOX)
Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
Drug: cediranib maleate
Other Names:Drug: oxaliplatin
Other Names:Drug: leucovorin calcium
Other Names:Drug: fluorouracil
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 cancers.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229111
|United States, Ohio|
|Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Ireland Cancer Center Landerbrook Health Center|
|Mayfield Heights, Ohio, United States, 44124|
|Lake University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|UHHS-Chagrin Highlands Medical Center|
|Orange Village, Ohio, United States, 44122|
|UH-Seidman Cancer Center at Saint John Medical Center|
|Westlake, Ohio, United States, 44145|
|Principal Investigator:||Smitha Krishnamurthi||Case Comprehensive Cancer Center|