Selumetinib in Treating Patients With Biliary Cancer That Cannot Be Removed By Surgery

Completed · Phase 2

Conditions studied: Liver and Intrahepatic Biliary Tract Cancer, Recurrent Extrahepatic Bile Duct Cancer, Unresectable Extrahepatic Bile Duct Cancer

In brief

This phase II trial is studying how well selumetinib works in treating patients with biliary cancer that cannot be removed by surgery. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00553332

Run by

National Cancer Institute (NCI)

People needed

29

Starts

2007-11-01

Expected to finish

2013-01-01

Last updated by the study team

2016-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed biliary tract carcinoma
• Surgically unresectable disease
• Meets any of the following criteria for biliary cancers only:
• Received ≤ 1 prior systemic anticancer therapy, including chemoembolization
• Received prior cryotherapy, radiofrequency ablation, ethanol injection, transarterial chemoembolization, or photodynamic therapy AND meets the following criteria:
• More than 6 weeks have elapsed since any of the prior therapy described above
• Indicator lesion(s) must be outside the area of prior treatment OR must demonstrate clear evidence of disease progression if the only indicator lesion is inside the prior treatment area
• Indicator lesion must have clearly distinct edges on CT scan
• Prior radiotherapy with or without the use of a fluoropyrimidine as a radiosensitizer is allowed, provided more than 12 weeks have elapsed since treatment
• Fresh or paraffin-embedded tissue from tumor blocks must be available for review
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan
• No known brain metastases
• Life expectancy > 12 weeks
• ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
• ANC ≥ 1,500/μL
• Platelet count ≥ 75,000/μL
• Total bilirubin ≤ 2 times upper limit of normal(ULN)
• AST or ALT ≤ 3 times ULN
• Serum albumin ≥ 2.5 mg/dL
• INR ≤ 1.5 (not receiving anticoagulation therapy)
• Creatinine normal or creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile women must use effective contraception during and for four weeks after the last dose of AZD6244
• Fertile men must use effective contraception during and for 16 weeks after the last dose of AZD6244

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Michigan Cancer Center (UMCC) Research Base — Ann Arbor, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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