Combining Erlotinib Plus Bevacizumab and Gemcitabine Plus Capecitabine to Treat Advanced Pancreatic Cancer (TARGET)
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Recurrent carcinoma of the pancreas, Adenocarcinoma of the pancreas, Stage II carcinoma of the pancreas, Stage III carcinoma of the pancreas, Stage IVA carcinoma of the pancreas, Stage IVB carcinoma of the pancreas
Eligibility Criteria
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
Sites / Locations
- The Royal Marsden Foundation Hospital NHS Trust