Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT02520141|
Recruitment Status : Recruiting
First Posted : August 11, 2015
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Laboratory Biomarker Analysis Biological: Ramucirumab||Phase 2|
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Ramucirumab for Advanced, Pre-Treated Biliary Cancers|
|Actual Study Start Date :||December 29, 2015|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Treatment (ramucirumab)
Patients receive ramucirumab IV over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Progression free survival of ramucirumab in advanced biliary cancers [ Time Frame: From the date of treatment start to the date of disease progression or to the date of death, whichever occurs first, or to the last follow-up date if patients are alive without disease progression, assessed up to at least 3 months post-treatment ]Progression free survival is measured using 95% confidence intervals.
- Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 28 days ]Unacceptable toxicities will also be monitored closely for the study drug using the method of Thall et al (1995).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520141
|Contact: Milind Javleemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Milind Javle 713-792-2828|
|Principal Investigator: Milind Javle|
|Principal Investigator:||Rachna T Shroff||M.D. Anderson Cancer Center|