Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
50

Summary

Conditions
  • Stage IIIA Gallbladder Cancer AJCC v7
  • Cholangiocarcinoma
  • Unresectable Gallbladder Carcinoma
  • Liver and Intrahepatic Bile Duct Carcinoma
  • Stage III Gallbladder Cancer AJCC V7
  • Stage III Intrahepatic Cholangiocarcinoma AJCC v7
  • Stage IIIB Gallbladder Cancer AJCC v7
  • Stage IV Gallbladder Cancer AJCC v7
  • Stage IVA Gallbladder Cancer AJCC v7
  • Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7
  • Stage IVB Gallbladder Cancer AJCC v7
  • Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. Determine the progression-free survival (PFS) of ramucirumab in advanced biliary cancers (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who have received prior chemotherapy. SECONDARY OBJECTIVES: I. Determine the response rate (RR) a...

PRIMARY OBJECTIVES: I. Determine the progression-free survival (PFS) of ramucirumab in advanced biliary cancers (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who have received prior chemotherapy. SECONDARY OBJECTIVES: I. Determine the response rate (RR) and disease control rate (partial response + complete response + stable disease) of ramucirumab in advanced biliary cancers. II. Determine overall survival (OS) of ramucirumab in advanced biliary cancers. III. Evaluate the toxicity of ramucirumab in advanced biliary cancers. EXPLORATORY OBJECTIVES: I. Correlate the carbohydrate antigen (CA) 19-9 response (defined as > 50% decrease from baseline) with tumor response, PFS and OS. II. Correlate baseline tumor gene expression profile with PFS. III. Correlate pre- and post-therapy computed tomography (CT) imaging to quantify iodine content, atomic numbers, and Z-values and correlate with response. OUTLINE: Patients receive ramucirumab intravenously (IV) over 60 minutes 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 at 30 days and then every 3 months thereafter.

Tracking Information

NCT #
NCT02520141
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Rachna T Shroff M.D. Anderson Cancer Center