cetuximab and bevacizumab with or without gemcitabine to treat metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: eligible patients with metastatic pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine


Eligibility criteria:
inclusion criteria: * the patient has provided signed written informed consent. * the patient is ≥18 years of age. * the patient has histologically or cytologically-confirmed pancreatic adenocarcinoma not amenable to curative treatment with surgery or has documented or suspected extrapancreatic metastases. * the patient has either (a) measurable disease as defined by response evaluation criteria in solid tumors version 1.0 (recist) or (b) non-measurable disease with an elevated baseline ca19-9 level (≥2 x the upper limit of normal \[uln\]). * the patient's eastern cooperative oncology group (ecog) performance status is ≤2. * the patient has adequate hematologic function as defined by an absolute neutrophil count (anc) ≥1500/mm3 and a platelet count ≥100,000/mm3 obtained within 2 weeks prior to the first dose of study medication. * the patient has adequate hepatic function as defined by a total bilirubin ≤2.0 mg/dl and transaminases ≤5.0 x uln obtained within 2 weeks prior to the first dose of study medication. * the patient has adequate renal function as defined by serum creatinine ≤2.0 x uln and urine dipstick for proteinuria ≤1+ obtained within 2 weeks prior to the first dose of study medication. if urine dipstick is ≥2+, then a 24-hour urine for protein must demonstrate \< 1000 mg of protein in 24 hours to allow participation in the study. urinalysis is also acceptable. * if the patient is on full-dose anticoagulation therapy (eg, warfarin or low molecular weight \[lmw\] heparin), the following criteria must be met: * the patient has an in-range international normalized ratio (\[inr\]usually between 2 and 3) on a stable dose of oral anticoagulant or be on a stable dose of lmw heparin * the patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices) * if the patient is not on full-dose anticoagulation therapy, the following criteria must be met: * the patient has adequate coagulation function as defined by inr ≤1.5 * the patient has a partial thromboplastin (ptt) ≤uln obtained within 2 weeks prior to the first dose of study medication * if a woman, the patient agrees to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study. if a male and sexually active, the patient agrees to use effective contraception. * the patient is accessible for treatment and follow-up. patients enrolled in this trial must be treated at the participating center. exclusion criteria: * endocrine tumors or lymphoma of the pancreas * known brain metastases * prior therapy with an epidermal growth factor receptor (egfr) inhibitor or vascular endothelial growth factor (vegf) inhibitor * prior chemotherapy, hormonal therapy, or radiation therapy for advanced pancreatic cancer, patients who received chemotherapy and/or radiation therapy in the adjuvant setting will be eligible as long as the adjuvant therapy was completed \>6 months prior * concurrent malignancy other than non-melanomatous skin cancer or carcinoma in situ of the cervix * concurrent treatment with other anti-cancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy * ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations * history of arterial thrombotic events within 9 months * history of uncontrolled hypertension (\>150/100 mmhg) not on a stable regimen of anti-hypertensive therapy * history of significant bleeding events or upper or lower gastrointestinal bleeding within 9 months * history of gastrointestinal perforation within 12 months * serious non-healing wound ulcer, bone fracture, or major surgical procedure with 28 days * if a woman, is pregnant or lactating * an employee of the investigator or study center as well as family members of the employees