Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: bevacizumab; oxaliplatin; Capecitabine; Capecitabine
Intervention description: 10 mg/kg intravenously over 30-90 minutes on day 1; 85 mg/m2 intravenously over 2 hours on day 1.; Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort; Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the colon; recurrent colon cancer; stage IV colon cancer; adenocarcinoma of the rectum; recurrent rectal cancer; stage IV rectal cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as capecitabine, and oxaliplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in
      different ways. Some find tumor cells and kill them or carry tumor-killing substances to
      them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may
      also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine
      and oxaliplatin together with bevacizumab may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine
      together with bevacizumab works in treating patients with metastatic or recurrent colorectal
      cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically documented adenocarcinoma of the colon or rectum

               -  Metastatic or recurrent disease not amenable to potentially curative treatment
                  (e.g., inoperable metastatic disease)

          -  No leptomeningeal or brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥ 2,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  AST/ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if known liver
             metastases)

          -  Bilirubin < 1.5 times ULN

          -  Creatinine clearance > 50 mL/min

          -  No unstable or poorly controlled hypertension (> 150/100 mm Hg)

               -  Patients who have recently started or adjusted antihypertensive medications are
                  eligible provided blood pressure is < 140/90 mm Hg on any new regimen for at
                  least 3 different observations over 14 days

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during study and for at least 3-4
             months after study completion

          -  No arterial or venous thrombosis (including cerebrovascular accident) within the last
             3 months

          -  No known, existing, uncontrolled coagulopathy

          -  No clinically significant cardiac disease

          -  No congestive heart failure

          -  No symptomatic coronary artery disease

          -  No cardiac arrhythmias not well controlled with medication

          -  No myocardial infarction within the last 12 months

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to oxaliplatin, capecitabine, or bevacizumab

          -  No 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 patient at high risk from
             treatment complications

        PRIOR CONCURRENT THERAPY:

          -  At least 4 weeks since prior sorivudine or brivudine

          -  At least 6 months since prior adjuvant treatment with fluorouracil and leucovorin
             calcium or a fluorouracil and leucovorin calcium-based regimen

          -  No major surgery within 4 weeks without complete recovery

          -  No prior chemotherapy for metastatic/recurrent disease

          -  No cancer immunotherapy or other biologic therapy while on therapy

          -  No radiotherapy while on study

          -  No hormonal therapy for cancer while on study

          -  No full-dose warfarin (INR of > 1.5), heparin (> 10,000 units/day), or thrombolytic
             agents

          -  Allopurinol and cimetidine should be discontinued prior to starting on this regimen