Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Erlotinib; gemcitabine
Intervention description: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.; The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent pancreatic cancer; stage IV pancreatic cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
      growth. Giving gemcitabine together with erlotinib may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib
      works in treating patients with metastatic or recurrent pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed locally advanced, metastatic or recurrent
             pancreatic carcinoma

          -  Must have measurable disease, defined as at least one lesion that can be accurately
             measured in at least one dimension

          -  No prior chemotherapy for metastatic or recurrent disease is allowed. Prior adjuvant
             chemotherapy is allowed provided that patients did not receive gemcitabine and the
             chemotherapy was completed > six months prior to initiation of study therapy. Prior
             erlotinib therapy is not allowed

          -  Available tumor specimen that was obtained at the time of diagnosis and/or prior to
             study entry is highly encouraged

          -  Age ≥ 18 years

          -  Life expectancy greater than 3 months

          -  Zubrod performance status ≤ 2

          -  Patients must have normal organ and marrow function as defined below:

          -  leukocytes ≥ 3,000/μL

          -  absolute neutrophil count ≥ 1,500/ μL

          -  platelets ≥ 100,000/ μL

          -  total bilirubin ≤ 1.5 X institutional upper limit of normal

          -  AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal, unless the liver is
             involved with tumor, in which case the AST/ALT must be ≤ 5 X institutional upper limit
             of normal

          -  creatinine clearance ≥ 50 mL/min/1.73 m2, as measured by 24hour collection OR

          -  creatinine ≤ 1.5 X institutional upper limit of normal

          -  The effects of erlotinib and gemcitabine on the developing human fetus at the
             recommended therapeutic doses are unknown. Women of child-bearing potential and men
             must agree to use adequate contraception prior to study entry and for the duration of
             study participation

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients may not be receiving any other investigational agents.

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to erlotinib or gemcitabine.

          -  Secondary primary malignancy. Concurrent or history of another malignancy < 5 years.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that
             would limit compliance with study requirements.

          -  Pregnant women are excluded from this study because erlotinib and gemcitabine have the
             potential for teratogenic or abortifacient effects. Breastfeeding should be
             discontinued if the mother is treated with study drugs.

          -  Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy.