Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma
Condition: Pancreatic Cancer
MeSH terms: Adenocarcinoma
Intervention: Avastin; Tarceva; Radiation Therapy
Intervention description: Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy; Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy; Radiation to the pancreas Monday through Friday for 28 treatments
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Locally advanced; Unresectable

Summary:

      The primary purpose of this trial is to define the maximum tolerated and/or recommended phase
      II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy
      for carcinoma of the pancreas. An additional primary objective is to describe the frequency
      and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary
      objectives include describing 1-year disease-free survival and overall survival rates as well
      as to estimate clinical and pathologic complete response rates associated with this regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, T1-4,
             N0-1, M0. Patients should have disease for which combined modality therapy is
             indicated.

          -  Performance status 0-2

          -  Life expectancy > 3 months

          -  Adequate hematologic, renal, hepatic function

          -  Calculated creatinine Cl > 50 mL/min

          -  Use of effective means of contraception in patients of child-bearing potential.

        Exclusion Criteria:

          -  No prior therapy for pancreatic cancer

          -  Previous treatment with bevacizumab or erlotinib

          -  Evidence of duodenal invasion or gastric outlet obstruction

          -  Presence of bleeding diathesis or coagulopathy

          -  History or prior arterial thrombotic event

          -  Conditions leading to inadequate gastrointestinal tract absorption

          -  Poorly controlled diarrhea .

          -  Presence of baseline proteinuria or renal dysfunction (CrCl < 50 (Cockcroft-Gault
             equation)

          -  Inadequately controlled hypertension

          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure

          -  Clinically significant peripheral vascular disease

          -  Presence of central nervous system or brain metastases

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, anticipation of need for major surgical procedure during the course of
             the study

          -  Minor surgical procedures such as fine needle aspirations or core biopsies within 7
             days prior to Day 0

          -  Pregnant or lactating females

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to Day 0

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  Inability to comply with study and/or follow-up procedures

          -  Treatment for other carcinomas within the last five years, except cured non-melanoma
             skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer
             with a current PSA of <1.0 mg/dL on 2 successive evaluations, at least 3 months apart,
             with the most recent evaluation no more than 4 weeks prior to entry.

          -  Comorbid conditions that would complicate safety or compliance