Phase II Trial Evaluating OS With Therasphere® + 2nd-Line FOLFOX in Pancreatic Liver Mets
Condition: Liver Cancer; Pancreatic Cancer
Intervention: FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin); TheraSpheres
Intervention description: The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.; TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver. TheraSpheres have restricted approval from the United States Food and Drug Administration (FDA) for the treatment of hepatocellular liver cancer; but has not yet been approved for the treatment of pancreatic cancer that has spread to the liver.
Intervention MeSH terms: Leucovorin; Folic Acid; Fluorouracil; Oxaliplatin; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: liver; pancreas; chemotherapy; radiotherapy

Summary:

      The purpose of this study is to evaluate the safety and impact on survival with treatment
      with 90-Y glass microspheres in conjunction with leucovorin, 5-fluorouracil (5-FU) and
      oxaliplatin (FOLFOX) as second-line treatment with in patients gemcitabine-refractory
      metastatic pancreatic cancer with predominantly liver metastases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have metastatic pancreatic cancer with predominantly liver metastatic
             disease (> 50%), as determined by the principal investigator (PI0 and referring
             medical oncologist that have progressed on gemcitabine-based chemotherapy.

          -  Patients can have solitary, multifocal unilobar, or bilobar disease.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to
             2

          -  No prior radiation or embolization of the liver

          -  Childs-Pugh score ≤ 7

          -  Lung shunting that predicts lung dose to be ≤ 30 Gy in a single treatment

          -  The effects of TheraSpheres on the developing human fetus at the recommended
             therapeutic dose are unknown. For this reason and because radioactive spheres are
             known to be teratogenic, women of child-bearing potential and men must agree to use
             adequate contraception (hormonal or barrier method of birth control; abstinence) prior
             to study entry and for the duration of study participation. Should a woman become
             pregnant or suspect she is pregnant while participating in this study, she should
             inform her treating physician immediately.

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Adequate baseline hematopoietic function:

               -  total white blood cell count equal to or greater than 3,000/mm^3

               -  absolute granulocyte count greater than 1,500/mm^3

               -  platelet count equal to or greater than 50,000/mm^3

               -  Hemoglobin > 8.0

        Exclusion Criteria:

          -  Patients currently receiving any other investigational agents

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study because TheraSpheres are radioactive and
             radiation is a known agent with the potential for teratogenic or abortifacient
             effects. Because there is an unknown but potential risk for adverse events in nursing
             infants secondary to treatment of the mother with TheraSpheres, breastfeeding should
             be discontinued if the mother is treated with TheraSpheres.

          -  Initiation of second-line chemotherapy not consisting of FOLFOX

          -  Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy. In addition, antiretrovirals are known
             radiation sensitizers and could dramatically increase the risk of fulminant hepatic
             failure. Therefore, human immunodeficiency virus(HIV)-positive patients are excluded
             from the study because of possible lethal side effects.

          -  Bulk disease (tumor volume > 70% of the target liver volume)

          -  Aspartic transaminase (AST) or alanine transaminase (ALT) > 5 times upper limit of
             normal (ULN)

          -  Bilirubin > 2 mg/dL

          -  Child-Pugh score > 7

          -  Tumor volume > 50% of liver combined with an albumin < 3 g/dL

          -  Complete occlusion of main portal vein causing portal hypertension