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:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of AZD2171 (Cediranib) With Modified FOLFOX6 in Patients With Advanced Biliary Cancers|
- The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 3 years ]The number of patients with a Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- Tabulation of the Toxicity Profile of the Combination Therapy [ Time Frame: Up to 3 years ]Number of patients that experienced >/= grade 3 treatment related toxicities (definite, probable, possible).
- Progression Free Survival [ Time Frame: Up to 3 years ]Time in months that evaluable subjects survived progression free
- Estimation of Overall Survival [ Time Frame: Up to 3 years ]Time of overall response
- Identification of Factors That Predict Survival [ Time Frame: Up to three years ]Factors that predict survival will be identified by Cox model or extended Cox model.
|Study Start Date:||October 2010|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (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|