Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Bevacizumab; Floxuridine; Irinotecan; Leucovorin
Intervention MeSH terms: Leucovorin; Bevacizumab; Irinotecan; Floxuridine; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Summary:

      RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, 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 block the ability of tumor cells to grow and spread. Others
      find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab
      may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving
      combination chemotherapy together with bevacizumab may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
      with bevacizumab works in treating patients with stage IV colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have stage IV, histologically confirmed diagnosis of Adenocarcinoma of
             the colon.

          2. Patients must have bi-dimensionally measurable disease since the purpose of this study
             is to determine efficacy of treatment.

          3. Patients must be previously untreated.

          4. Patients must be over the age of 18 years.

          5. Patients may not be pregnant. Patients of childbearing years must be using
             contraception.

          6. Patients must have ECOG performance status of 0-1 or KPS of at least 70.

          7. Patients must have life expectancy of ≥ two months.

          8. Patients must have a white blood cell count of ≥1000/mm³ ANC > 1.0, platelets >
             100,000/mm³.

          9. Patients must have adequate renal function as documented by a serum creatinine of ≤
             1.5 mg/dl.

         10. Patients must have a bilirubin of ≤ 1.5 mg/dl and an SGOT of ≤ three times normal for
             patients with no liver disease, and ≤ five times normal for those with liver
             metastases.

         11. Patients must be informed of the investigational nature of the study and give written
             informed consent.

         12. Patients must have indwelling central venous catheter or good peripheral intravenous
             catheter, preferably a port-a-cath.

         13. Patients may have had prior surgery for their colorectal cancer. Patients must be at
             least 8 weeks beyond surgery and recovered from all effects of surgery.

         14. Patients enrolled in this study may have a history of prior malignancy (5 years ago)
             provided that the patient is currently disease-free.

        Exclusion Criteria:

          1. Patients who have had prior chemotherapy or radiation therapy for their colorectal
             cancer, with exception of adjuvant chemo/radiation therapy.

          2. Patients receiving concomitant radiation, hormonal therapy, chemotherapy, or
             immunotherapy.

          3. Patients receiving any investigational drug within 30 days prior to start of this
             study.

          4. Patients with serious underlying medical illnesses (including Congestive Heart Failure
             New York Heart Association Functional Classification 2-4) or active infection.

          5. Patients with central nervous system metastasis must have completed radiation prior to
             entry into this protocol.

          6. Patients with psychiatric conditions or associated conditions which would make
             participating in this study dangerous to their health.

          7. Patients with uncontrolled hypertension.