NCT02520141

Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery

A Phase II Study of Ramucirumab for Advanced, Pre-Treated Biliary Cancers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well ramucirumab works in treating patients with previously treated biliary cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Detailed 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) 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.

Conditions

• Cholangiocarcinoma
• Liver and Intrahepatic Bile Duct Carcinoma
• Stage III Gallbladder Cancer AJCC v7
• Stage III Intrahepatic Cholangiocarcinoma AJCC v7
• Stage IIIA Gallbladder Cancer 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
• Unresectable Gallbladder Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Ramucirumab	Given IV

Timeline

• Start date: 2015-12-29
• Primary completion: 2022-06-29
• Completion: 2022-06-29
• First posted: 2015-08-11
• Last updated: 2023-06-15
• Results posted: 2023-06-15

Locations

1 site across 1 country: United States