Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Chemotherapy and Radiation Therapy for Pancreatic Cancer
Condition: Extrahepatic Bile Duct Cancer; Nausea; Vomiting; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma; Nausea; Vomiting
Intervention: aprepitant; gemcitabine hydrochloride; capecitabine; fluorouracil; radiation therapy; questionnaire administration; quality-of-life assessment; nausea and vomiting therapy; management of therapy complications
Intervention description: Given PO; Given IV; Given PO; Given IV; Undergo radiation therapy; Ancillary studies; Ancillary studies; Receive aprepitant; Receive aprepitant
Intervention MeSH terms: Gemcitabine; Capecitabine; Fluorouracil; Aprepitant; Antiemetics
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial is studying how well aprepitant works in preventing nausea and
      vomiting in patients undergoing chemotherapy and radiation therapy for pancreatic cancer.
      Antiemetic drugs, such as aprepitant may help lessen or prevent nausea and vomiting in
      patients receiving chemotherapy and radiation therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of carcinoma arising from the pancreas

          -  Resected or unresectable pancreatic cancer, potentially resectable, or resectable
             (neoadjuvant) disease (stage II and III); stage IV patients with symptomatic back pain
             requiring palliation are also eligible at the discretion of the Principal Investigator
             (PI); resected patients, i.e. - "Whipple" of biliary ductal cancers are also eligible
             at the discretion of the PI

          -  Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

          -  Evidence of disease; this can be measurable, evaluable, or nonmeasurable

          -  Estimated life expectancy of at least 12 weeks

          -  Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 X 10^9/L

          -  Platelets >= 100 X 10^9/L

          -  Hemoglobin >= 9 g/dL

          -  Bilirubin =< 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase (AP) =< 3.0 ULN ( AP =< 5 x ULN is acceptable if liver has tumor
             involvement)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 ULN (AST
             and ALT =< 5 x ULN is acceptable if liver has tumor involvement)

          -  Albumin >= 3.0 g/dL

          -  Signed informed consent from patient

          -  Male and female patients with reproductive potential must use an approved
             contraceptive method (e.g., intrauterine device, birth control pills, or barrier
             device) during and for 3 months after the study

        Exclusion Criteria:

          -  Active infection (at the discretion of the investigator)

          -  Neuroendocrine tumor of the pancreas

          -  Documented brain metastasis; brain imaging in symptomatic patients is required to rule
             out metastases, but not required in asymptomatic patients

          -  Pregnancy

          -  Breast feeding

          -  Serious concomitant systemic disorders incompatible with the study (at the discretion
             of the investigator)

          -  Use of any investigational agent within 4 weeks before enrollment into the study

          -  Significant cardiovascular disease in the form of abnormal electrocardiogram (ECG)
             coupled with clinical features of recent or recurrent cardiac disease (including
             myocardial infarction, angina or hypertension)

          -  Prior treatment with chemotherapy for pancreatic cancer

          -  Clinically significant effusions (pleural or peritoneal) that cannot be drained