Combining Erlotinib Plus Bevacizumab and Gemcitabine Plus Capecitabine to Treat Advanced Pancreatic Cancer (TARGET)

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Locally advanced or metastatic disease
• Not amenable to curative resection
• No invasion of adjacent organs (e.g., duodenum or stomach) by CT scan
• Unidimensionally measurable disease as assessed by CT in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
• No evidence of brain metastasis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

• Greater than 3 months

Hematopoietic:

• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic:

• Bilirubin ≤ upper limit of normal
• Serum albumin > 26 g/litre

Renal:

• Creatinine ≤ 180 micromoles/litre OR
• Creatinine clearance ≥ 50 mL/min

Cardiovascular:

• No clinically significant cardiovascular disease
• No uncontrolled hypertension (i.e., blood pressure > 150/90 mm Hg on medication)

• No arterial thromboembolic event within the past 6 months, including any of the following:

  • Myocardial infarction
  • Unstable angina pectoris
  • Cerebrovascular accident
  • Transient ischemic attack
• No New York Heart Association grade II-IV congestive heart failure
• No serious cardiac arrhythmia requiring medication

OTHER:

• Not pregnant or breast feeding
• Fertile patients must use effective contraception during study participation
• No serious or non-healing wound, ulcer, or bone fracture
• No infection requiring parenteral antibiotics
• No major bleeding diathesis or coagulopathy
• No significant traumatic injury within the past 28 days
• No surgery within the last 28 days or anticipation for the need for major surgery during the course of study treatment
• No other active malignancy except non-melanoma skin cancer and cervical cancer in-situ
• No history of known dihydropyrimidine dehydrogenase (DPD) deficiency
• No lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication

PRIOR CONCURRENT THERAPY:

• No previous chemotherapy, radiotherapy or other investigational drug treatment for metastatic disease (including VEGF or EGFR antagonists)
• No previous preoperative or adjuvant chemotherapy, radiotherapy or other investigational drug treatment.
• No full dose anti-coagulation (i.e. warfarin or full dose low molecular weight heparin) prior to starting study treatment.
• No ongoing treatment with aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration