Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: erlotinib hydrochloride; immunohistochemistry staining method; laboratory biomarker analysis
Intervention description: Oral; Correlative Study; Correlative Study
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer

Summary:

      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with
      stage III or stage IV pancreatic cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

               -  Locally advanced inoperable or metastatic disease (stage III or IV disease)

          -  No more than 1 prior systemic therapy

          -  Patients who have not received 1 prior systemic therapy must meet 1 of the following
             criteria:

               -  Ineligible for or refused chemoradiotherapy AND has stage III disease

               -  Ineligible for or refused gemcitabine hydrochloride-based chemotherapy AND has
                  stage IV disease

          -  No brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy > 3 months

          -  WBC > 3,000/mm³

          -  ANC > 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  Bilirubin ≤ 2 mg/dL

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with
             documented liver metastases)

          -  Creatinine < 1.5 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after
             completion of study therapy

          -  No uncontrolled comorbid illness that is likely to increase toxicity of the study drug
             or to interfere with toxicity evaluation

          -  No known allergy to the study drug or its excipients

          -  No symptomatic interstitial pulmonary disease

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Prior adjuvant therapy allowed provided it was completed at least 28 days prior to
             study entry

          -  No prior EGFR-inhibitor

          -  No concurrent drugs that are known to be strong inducers or inhibitors of the CYP450
             enzyme system

          -  No concurrent Hypericum perforatum (St. John's wort)

          -  No concurrent investigational or commercial agents or therapies with the intent to
             treat the patient's malignancy