Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery
Last updated on July 2021Recruitment
- 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