Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer
Condition: Pancreas Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Lapatinib and Capecitabine
Intervention description: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles
Intervention MeSH terms: Capecitabine; Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreas cancer; lapatinib; capecitabine

Summary:

      Patients are being asked to participate in this study who have locally advanced or metastatic
      pancreatic cancer (cancer of the pancreas that has spread to another part of the body) that
      has gotten worse after first-line chemotherapy.

      The purpose of this study is to see if the drugs, Capecitabine and Lapatinib (two
      chemotherapy agents), prolong survival and improve quality of life as compared to supportive
      care alone.

      Lapatinib in combination with a drug called capecitabine, has been approved by the Food and
      Drug Administration (FDA) for the treatment of metastatic breast cancer. It has not yet been
      approved to treat this type of cancer. Both of these drugs are pills.

      This research is being done because it is not known if the combination of Capecitabine and
      Lapatinib is better than supportive care alone for pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the pancreas

          -  Prior failed 1st line gemcitabine therapy for metastatic disease or relapsed within
             six months of completion of gemcitabine adjuvant therapy

          -  Prior capecitabine or 5fu is allowed in the setting of radiation

          -  Must either be able to swallow or receive enteral nutrition via gastrostomy feeding
             tube

          -  Cardiac ejection fraction within institutional range of normal as measured by
             echocardiogram

          -  ECOG performance status 0-2

          -  Signed informed consent form

          -  Adequate hepatic, bone marrow, and renal function

        Exclusion Criteria:

          -  Any prior treatment with lapatinib, or any anti-HER2 treatment or any anti-EGFR
             treatment

          -  Not recovered from adverse events to a toxicity grade </= 1 due to prior chemotherapy

          -  More than one prior chemotherapy regimens

          -  Known brain metastases, uncontrolled seizure disorders, encephalitis, or multiple
             sclerosis

          -  HIV positive on antiretroviral therapy

          -  Pregnant or lactating

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to lapatinib or capecitabine

          -  Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative
             colitis)

          -  Known history of uncontrolled or symptomatic angina, arrhythmia, or congestive heart
             failure

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection or psychiatric illness/ social situations that would limit compliance with
             study requirements

          -  Known dihydropyrimidine dehydrogenase deficiency

          -  Concurrent malignancy unless the subject has been curatively treated and disease free
             for >/= 2 years or the cancer was non-melanoma skin cancer or early cervical cancer.

          -  Creatinine clearance < 30 mL/min

          -  Absolute neutrophil count < 1500, platelets < 75,000

          -  Transaminases > 3.0 times the upper limit of normal, except in known hepatic
             metastasis, wherein they must be < 5.0 times the upper limit of normal

          -  Total bilirubin > 1.5 times the ULN, > 2.5 x ULN if patient has Gilbert's syndrome