Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: cetuximab; bevacizumab; gemcitabine; cetuximab
Intervention description: I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1; 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.; 1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks.; I.V.infusions of 250 mg/m2 (over 60 minutes) weekly
Intervention MeSH terms: Bevacizumab; Cetuximab; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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