Genistein, Gemcitabine, and Erlotinib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: genistein; erlotinib hydrochloride; gemcitabine hydrochloride
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride; Genistein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; stage III pancreatic cancer; stage IV pancreatic cancer; recurrent 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. Genistein may help gemcitabine and erlotinib kill more tumor cells by making tumor
      cells more sensitive to the drugs.

      PURPOSE: This phase II trial is studying how well giving genistein together with gemcitabine
      and erlotinib works in treating patients with locally advanced or metastatic pancreatic
      cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed pancreatic adenocarcinoma

               -  Locally advanced or metastatic disease by radiological evidence

          -  Must have biopsy material consisting of 10 unstained slides or paraffin-embedded
             tissue blocks available for correlative studies

          -  No endocrine tumor or lymphoma of the pancreas

          -  No history of CNS (central nervous system) metastases

        PATIENT CHARACTERISTICS:

          -  SWOG (Southwest Oncology Group) performance status 0-1

          -  Life expectancy ≥ 12 weeks

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Bilirubin < 2.0 mg/dL

          -  AST (aspartate aminotransferase) and ALT (alanine aminotransferase) < 1.5 times upper
             limit of normal

          -  Creatinine < 1.5 mg/dL

          -  Albumin > 2.5 g/dL

          -  INR (international normalized ratio) < 1.3 (in the absence of ongoing treatment with
             warfarin)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active infection

          -  No condition that would limit the ability to receive oral medications

          -  No requirement for a gastrostomy tube for the administration of drugs

          -  No serious concurrent systemic disorder, that, in the opinion of the investigator, is
             incompatible with the study

          -  No active second primary malignancy within the past year except in situ carcinoma of
             the cervix or adequately treated basal cell carcinoma of the skin

          -  No allergy to any study drug

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for metastatic disease

               -  Prior adjuvant chemotherapy allowed provided it was completed at least 6 months
                  ago

          -  No prior gemcitabine hydrochloride or epidermal growth factor receptor-inhibiting
             agents

          -  No other concurrent chemotherapy, immunotherapy, tumor-directed hormonal therapy, or
             radiotherapy

          -  No other concurrent investigational agents

          -  No other concurrent antitumor therapy