Selumetinib in Treating Patients With Locally Advanced or Metastatic Liver Cancer

Completed · Phase 2

Conditions studied: Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer

In brief

This phase II trial is studying selumetinib to see how well it works in treating patients with locally advanced or metastatic liver cancer. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

Key facts

Study ID

NCT00604721

Run by

National Cancer Institute (NCI)

People needed

19

Starts

2007-11-01

Expected to finish

2012-06-01

Last updated by the study team

2014-05-28

Who can join

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

You may qualify if…

• Meets 1 of the following criteria:
• Histologically or cytologically confirmed hepatocellular carcinoma
• Serum alpha fetoprotein > 1000ng/dL with characteristic imaging findings coupled with the appropriate clinical scenario (i.e., chronic hepatitis and/or cirrhosis)
• Child's A or B cirrhosis allowed
• If Child's B cirrhosis is present, the patient may not have significant encephalopathy or ascites that requires paracentesis and must meet laboratory criteria (i.e., well-compensated Child's B)
• Metastatic disease (including any proven lymph node metastases) or localized disease not amenable to potentially curative transplant/locoregional/surgical therapy as determined by a qualified surgeon or tumor board
• Measurable disease, defined as at least one unidimensionally measurable ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• No known brain metastases
• ECOG performance status ≤ 2
• Life expectancy > 3 months
• Leukocytes ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelets ≥ 75,000/mm³
• Total bilirubin < 2 times upper limit of normal (ULN)
• AST/ALT < 5 times ULN
• Creatinine < 1.5 mg/dL or creatinine clearance ≥ 60 mL/min
• INR < 1.4
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment
• Willing to undergo protocol-required tumor biopsies (patients must also be able to have any anticoagulation held for an appropriate period of time)
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD6244 or its excipient Captisol®
• No refractory nausea and vomiting or chronic gastrointestinal diseases (e.g., inflammatory bowel disease) that would preclude adequate absorption
• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
• No active illicit substance or alcohol abuse

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
• Vanderbilt University — Nashville, Tennessee, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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