Safety and Efficacy Study Using Bevacizumab, Capecitabine and Oxaliplatin for Colorectal Cancer
Condition: Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Bevacizumab; Capecitabine; Oxaliplatin
Intervention description: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity; Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).; Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colon; rectum

Summary:

      This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine.
      This is an open-label study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  advanced, surgically unresectable CRC

          -  measurable disease, defined as at least one lesion that can be accurately measured in
             at least one dimension(histological confirmation of adenocarcinoma of the colon or
             rectum.

        ECOG performance status of 0, 1, or 2 Estimated life expectancy of at least 12 weeks.

          -  chemotherapy prior to the diagnosis of metastatic disease. The chemotherapy regimen
             must not have included oxaliplatin or bevacizumab. No prior therapy for metastatic
             disease is permitted.

          -  Evidence of adequate organ function, including:

          -  Evidence of adequate hepatic function,

          -  Evidence of adequate renal function INR <1.5 x ULN (unless taking warfarin in which
             case it must be in the therapeutic range). Patients on warfarin are allowed to
             participate.

          -  Absence of proteinuria on urine analysis· Patients with a history of prior
             non-colorectal malignancies are eligible if they have been disease-free for at least 5
             years prior to study entry and are deemed by the physician to be at low risk for
             recurrence. Patients with the following cancers are eligible if diagnosed and treated
             within the past 5 years: melanoma in situ, and basal cell and squamous cell carcinoma
             of the skin.

          -  Age > 18 yrs.

        Exclusion Criteria:

          -  Any systemic therapy administered for metastatic or locally recurrent disease.
             Patients who are considered candidates for surgical resection of metastatic and/or
             locally advanced disease.

          -  Any histology other than adenocarcinoma of the colon or rectum.

          -  Pregnancy or lactation at the time of patient entry or women of childbearing potential
             with no pregnancy test. Eligible patients of reproductive potential (both sexes) must
             agree to use adequate contraceptive methods during and for 6 months after study
             therapy.

          -  Serious concomitant medical conditions that, in the opinion of the investigator, would
             compromise the safety of the patient or compromise the patient's ability to complete
             the study.

          -  General Medical Concerns History of other disease, metabolic dysfunction, physical
             examination finding, or clinical laboratory finding giving reasonable suspicion of a
             disease or condition that contraindicates the use of an investigational drug or that
             might affect the interpretation of the results of the study or render the subject at
             high risk from treatment complications.

          -  Serious, uncontrolled, concurrent infection.

          -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, or anticipation of need for major surgical procedure during the course
             of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0.

          -  Proteinuria at baseline or clinically significant impairment of renal function.

          -  Serious, non healing wound, ulcer, or bone fracture

          -  Subjects who can not take oral medication