Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Condition: Pancreatic Cancer; Adenocarcinoma of the Pancreas
MeSH terms: Pancreatic Neoplasms
Intervention: Bevacizumab; Erlotinib; Gemcitabine
Intervention description: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.; Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.; Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.
Intervention MeSH terms: Bevacizumab; Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to learn whether or not the combination of gemcitabine,
      bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic
      cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop
      cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved
      by the FDA for the treatment of colorectal cancer but is still considered investigational for
      treating pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously untreated patients with unresectable or metastatic adenocarcinoma of the
             pancreas

          -  ECOG Performance Status 0-2

          -  18 years of age or older

          -  Radiographically measurable disease

          -  Expected survival of at least 4 months

          -  Creatinine of </= 2.0

          -  Adequate hepatic function

          -  Adequate hematopoietic function

          -  Use of effective means of contraception in subjects of child-bearing potential

        Exclusion Criteria:

          -  Warfarin anticoagulation

          -  Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor

          -  Coexistent malignant disease

          -  Current or recent (within 4 weeks) participation in a clinical trial

          -  Pregnancy

          -  Documented invasion of adjacent organs or major blood vessels

          -  Blood pressure of > 150/100mmHg

          -  Unstable angina

          -  NYHA Grade II or greater congestive heart failure

          -  History of myocardial infarction or stroke within 6 months

          -  Clinically significant peripheral vascular disease

          -  Evidence of bleeding diathesis of coagulopathy

          -  Presence of CNS or brain metastases

          -  Major surgical procedure, open biopsy, or significant traumatic event within 28 days

          -  Minor surgical procedures, fine needle aspirations or core biopsies within 7 days

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months

          -  Serious non-healing wound, ulcer or bone fracture