Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: bevacizumab; erlotinib hydrochloride; laboratory biomarker analysis
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV pancreatic cancer; adenocarcinoma of the pancreas; recurrent pancreatic cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the
      growth of pancreatic cancer by blocking blood flow to the tumor. Erlotinib may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
      bevacizumab together with erlotinib may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib
      works in treating patients with metastatic pancreatic cancer that did not respond to previous
      treatment with gemcitabine.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

          -  Documented extrapancreatic metastases

               -  Radiographically measurable disease not required

          -  Gemcitabine hydrochloride-refractory disease

               -  Has undergone 1-3 prior therapies for locally advanced or metastatic disease with
                  ≥ 1 regimen containing gemcitabine hydrochloride (alone or in combination with
                  other agents)

                    -  Treatment given in the adjuvant setting (radiotherapy and/or chemotherapy,
                       given either concurrently or systemically) does not count as prior therapy
                       as long as progressive disease occurs > 6 months after completion of
                       treatment

          -  No central nervous system (CNS) or brain metastases

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  International Normalized Ratio (INR) ≤ 1.5 (except in patients receiving full-dose
             warfarin)

          -  Bilirubin ≤ 2.0 mg/dL

          -  Creatinine ≤ 2.0 mg/dL

          -  AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if documented liver
             metastases)

          -  Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)

          -  No contact lense use during and for 14 days after completion of study treatment

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 6 months after
             completion of study treatment

          -  No history of other disease, metabolic dysfunction, or physical examination or
             clinical laboratory finding that contraindicates use of an investigational drug or
             precludes study compliance

          -  No history of serious systemic disease, including any of the following:

               -  Myocardial infarction within the past 6 months

               -  Stroke within the past 6 months

               -  Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)

               -  Unstable angina

               -  New York Heart Association class II-IV congestive heart failure

               -  Unstable symptomatic arrhythmia requiring medication

                    -  Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal
                       supraventricular tachycardia) allowed

               -  Peripheral vascular disease ≥ grade 2

          -  No significant traumatic injury within the past 28 days

          -  No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 at screening)

          -  No clinically significant impairment of renal function

          -  No serious, nonhealing wound, ulcer, or bone fracture

          -  No evidence of bleeding diathesis or coagulopathy

          -  No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
             abscess within the past 6 months

        PRIOR CONCURRENT THERAPY:

          -  More than 28 days since prior major surgery or open biopsy

          -  More than 7 days since prior fine-needle aspiration or core biopsy

          -  No prior antiangiogenesis agent (e.g., bevacizumab or an oral vascular endothelial
             growth factor receptor small molecule inhibitor) given together with an agent that
             disrupts epidermal growth factor receptor signaling (e.g., cetuximab or erlotinib
             hydrochloride) for locally advanced or metastatic pancreatic cancer

               -  Prior treatment with either one of the above alone allowed

          -  More than 4 weeks since prior and no concurrent participation in another clinical
             trial

          -  No other concurrent antineoplastic or antitumor agents, including chemotherapy,
             radiotherapy, immunotherapy, or hormonal anticancer therapy

          -  No concurrent major surgery

          -  No other concurrent investigational agents