Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: panitumumab; erlotinib hydrochloride; gemcitabine hydrochloride
Intervention description: Given IV; Given orally; Given IV
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the pancreas; duct cell adenocarcinoma of the pancreas; 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. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways.
      Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
      kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of
      pancreatic cancer by blocking blood flow to the tumor.

      PURPOSE: This randomized phase II trial is studying how well giving panitumumab together with
      gemcitabine and erlotinib works compared to giving gemcitabine and erlotinib alone in
      treating patients with metastatic pancreatic cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas (ductal or
             undifferentiated)

               -  Metastatic disease

          -  No islet cell, acinar cell, or cystadenocarcinomas

          -  No locally advanced disease

          -  No history or known presence of CNS metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 3 months

          -  ANC ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Total bilirubin ≤ 2 times upper limit of normal (ULN) (patients may be stented)

          -  AST ≤ 2.5 times ULN

          -  Creatinine ≤ 2.0 times ULN

          -  Magnesium ≥ lower limit of normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Willing to provide a stool specimen

          -  No malignancy diagnosed within the past 3 years except basal cell or squamous cell
             skin cancer, prostate cancer (Gleason < 7), or carcinoma in situ of the cervix

          -  No uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  No clinically significant cardiovascular disease (i.e., myocardial infarction,
             unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac
             arrhythmia) within the past year

          -  No known positive test(s) for HIV infection, hepatitis C virus, or acute or chronic
             active hepatitis B infection

          -  No liver dysfunction from cirrhosis or viral hepatitis

          -  No enteral hyperalimentation

          -  No grapefruit or grapefruit juice during the study

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior therapy

          -  More than 4 months since prior radiotherapy, immunotherapy, or biologic therapy

          -  More than 4 weeks since prior and no elective or planned major surgery

          -  More than 2 weeks since prior minor and no elective or planned surgery

          -  No prior cytotoxic chemotherapy for metastatic disease

               -  Adjuvant chemotherapy for completely resected disease or chemoradiotherapy for
                  locally advanced disease is allowed, provided it was administered > 6 months
                  prior to study entry

                    -  Adjuvant chemotherapy must not have contained an EGFR inhibitor

               -  Gemcitabine hydrochloride used as either a radiosensitizer or as maintenance
                  therapy is allowed, provided more than 6 months have elapsed since the last day
                  of treatment

          -  No prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule
             EGFR inhibitors (e.g., gefitinib hydrochloride, erlotinib hydrochloride, or lapatinib)

          -  No concurrent immunotherapy or radiotherapy

          -  No other concurrent chemotherapy

          -  No concurrent colony-stimulating factors during the first course of study therapy