Patients receive ramucirumab IV over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

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

Laboratory Biomarker Analysis

Ramucirumab

University of Texas MD Anderson Cancer Center Website

M D Anderson Cancer Center

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

Progression free survival is measured using 95% confidence intervals.

Unacceptable toxicities will also be monitored closely for the study drug using the method of Thall et al (1995).

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Unresectable Extrahepatic Bile Duct Carcinoma

Cisplatin

Gemcitabine Hydrochloride

Nab-paclitaxel

Mayo Clinic in Arizona

Mayo Clinic

Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers

A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

The Bayes factor single arm time-to-event model by Johnson & Cook will be used to monitor the PFS time.

Toxicity will be monitored closely using the method of Thall et al.

GM-CT-01 (280 mg/m2) combined with 5-FU (600 mg/m2) given 4 consecutive days in a 28 days cycle until disease progression.

Cancer of the Bile Duct

Gallbladder Cancer

GM-CT-01 at 280 mg/m2 given IV for 4 consecutive days in 28 days cycle until disease progression

GM-CT-01

5-FU given IV by infusion for 30, at 600 mg/m2 in combination with GM-CT-01 for 4 consecutive days in 28 days cycle until disease progression

5-Fluorouracil

Boston Medical Center

University of Michigan, Comprehensive Cancer Center

Barrett Cancer Center

Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer

Phase 2, Multi-center, Open-label Trial to Evaluate Efficacy and Safety of GM-CT-01 in Combination With 5-FU as First Line Chemotherapy in Patients With Advanced Biliary Cancer

A minimum of 18 subjects who meet the response evaluation criteria (per protocol population) will be enrolled in Stage 1. This require 2nd CT evaluation of tumor after minimum 2 cycles of treatments. CR, PR, SD and progressive disease (PD) as defined by RECIST criteria.

A minimum of 18 subjects who meet the response evaluation criteria (per protocol population) will be enrolled in Stage 1. This require 2nd CT evaluation of tumor after minimum 2 cycles of treatments. SD and progressive disease (PD) as defined by RECIST criteria.

cholangiocarcinoma/carbohydrate

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

Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers

Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer

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