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

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

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Capecitabine — DRUG
  Given PO
• Fluorouracil — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Leucovorin Calcium — DRUG
  Given IV
• Trametinib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Feb 28, 2014

Status verified

Aug 2017

Primary completion

Jan 31, 2017

Completion

Apr 30, 2017

Study Design

Enrollment

53 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Trametinib
  Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Chemotherapy
  Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15 (courses repeat every 28 days); or B) capecitabine PO BID on days 1-14 (courses repeat every 21 days). Patients treated until disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Survival [ Time Frame: Up to 2 years from registration ]

Locations (295)

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