Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery

Summary

This randomized phase II trial studies how well trametinib or combination chemotherapy works in treating patients with refractory or advanced biliary or gallbladder cancer or that cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving trametinib is more effective than combination chemotherapy in treating patients with biliary or gallbladder cancer.

Conditions

• Adult Cholangiocarcinoma
• Advanced Adult Hepatocellular Carcinoma
• BCLC Stage C Adult Hepatocellular Carcinoma
• BCLC Stage D Adult Hepatocellular Carcinoma
• Hilar Cholangiocarcinoma
• Localized Non-Resectable Adult Liver Carcinoma
• Recurrent Adult Liver Carcinoma
• Recurrent Childhood Liver Cancer
• Recurrent Extrahepatic Bile Duct Carcinoma
• Recurrent Gallbladder Carcinoma
• Stage II Gallbladder Cancer
• Stage III Childhood Hepatocellular Carcinoma
• Stage IIIA Gallbladder Cancer
• Stage IIIB Gallbladder Cancer
• Stage IV Childhood Hepatocellular Carcinoma
• Stage IV Distal Bile Duct Cancer
• Stage IVA Gallbladder Cancer
• Stage IVB Gallbladder Cancer
• Unresectable Extrahepatic Bile Duct Carcinoma

Interventions

DRUG

Capecitabine

Given PO

DRUG

Fluorouracil

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV

DRUG

Trametinib

Given PO

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Richard Kim · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2017-01-31

Completion

2017-04-30

Countries

• United States

Study Locations