FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer

Exclusion Criteria

• •Lactating woman unwilling to stop breast feeding for the duration of study participation and 30 days from the date of the last study drug administration
• •History of allergy to any of the chemotherapeutics or antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy.
• •Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-fluorouracil, or known DPD deficiency.
• •Serious, uncontrolled, intercurrent infection(s) or illnesses including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia.
• •Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
• •Current, recent (within 4 weeks of first infusion on this study) or planned participation in an investigational drug study.
• •Patients with documented DIC (disseminated intravascular coagulation).
• •Patients with a previous history of a bleeding diathesis or significant bleeding episode such as gastrointestinal bleeding or a CNS hemorrhage.
• •Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 12 months.
• •Presence of central nervous system or brain mets.
• •Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study.
• •Unwillingness to participate or inability to comply with the protocol for the duration of the study.
• •Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1.
• •Blood pressure \> 150/100 mmHg.
• •Unstable angina.
• •New York Heart Association (NYHA) Grade II or greater congestive heart failure.
• •History of myocardial infarction or stroke within 6 months.
• •Clinically significant peripheral vascular disease.
• •Evidence of bleeding diathesis or coagulopathy.
• •History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess within 28 days prior to Day 0.
• •Serious, non-healing wound, ulcer or bone fracture.
• •Carcinoma of any histology in close proximity to a major vessel, lung cavitation or history of hemoptysis.
• •Completion of previous chemotherapy regimen \< four weeks prior to the start of study treatment (within six weeks of study treatment for mitomycin C and nitrosureas), or with related toxicities unresolved prior to the start of study treatment.
• •Patients who are taking anti coagulation therapy such as coumadin or low molecular weight Heparin.
• •Patients who have an allergy against heparin.
• •Medical, social or psychological factors which would interfere with consent and follow up.
• •Known defective hemostasis, e.g. thrombocytopenia.
• •Patients receiving Hormone Replacement Therapy.