Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: bevacizumab; capecitabine
Intervention MeSH terms: Bevacizumab; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Summary:

      RATIONALE: 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. Drugs used in chemotherapy,
      such as capecitabine, work in different ways to stop the growth of tumor cells, either by
      killing the cells or by stopping them from dividing. Giving bevacizumab together with
      capecitabine may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with
      capecitabine works as first-line therapy in treating older patients with metastatic
      colorectal cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically* or cytologically* confirmed colorectal cancer

               -  Site of primary tumor must have been confirmed by endoscopy, radiography, or
                  surgery

               -  Metastatic disease NOTE: *Patients with a history of surgically treated
                  colorectal cancer who subsequently develop recurrent metastatic disease do not
                  require histologic or cytologic confirmation of metastatic disease unless an
                  interval of > 5 years has elapsed between initial primary surgery and the
                  development of metastases

          -  Measurable disease

               -  At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
                  OR ≥ 10 mm by spiral CT scan

          -  No known curative therapy exists

          -  No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or
             brain or CNS metastases)

        PATIENT CHARACTERISTICS:

        Age

          -  70 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  More than 3 months

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  No bleeding diathesis or coagulopathy

        Hepatic

          -  Bilirubin normal

          -  AST and ALT ≤ 3 times upper limit of normal (ULN)

          -  INR < 1.5 (unless on therapeutic anticoagulants)

          -  No unstable or uncompensated hepatic disease

        Renal

          -  Creatinine < 1.2 times ULN OR

          -  Creatinine clearance > 60 mL/min

          -  No unstable or uncompensated renal disease

        Cardiovascular

          -  No history of stroke

          -  No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)

          -  No myocardial infarction within the past year

          -  No New York Heart Association class II-IV congestive heart failure

          -  No unstable angina

          -  No serious cardiac dysrhythmia requiring medication

          -  No other clinically significant cardiovascular disease

          -  No other unstable or uncompensated cardiac disease

        Pulmonary

          -  No unstable or uncompensated respiratory disease

        Other

          -  Fertile patients must use effective contraception

          -  Able to receive oral medication

          -  No known hypersensitivity to fluorouracil or capecitabine

          -  No known dihydropyrimidine dehydrogenase deficiency

          -  No seizures not controlled by standard medical therapy

          -  No serious nonhealing wound, ulcer, or bone fracture

          -  No other malignancy within the past 5 years except completely excised nonmelanoma skin
             cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix

          -  No other severe or uncontrolled systemic disease

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior bevacizumab

        Chemotherapy

          -  Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment
             was administered > 6 months before the development of metastatic disease

          -  No prior chemotherapy for metastatic colon cancer

          -  No prior irinotecan or oxaliplatin

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  See Disease Characteristics

          -  More than 28 days since prior and no concurrent major surgery

          -  More than 28 days since prior open biopsy

          -  More than 7 days since prior fine needle aspiration or core biopsy

        Other

          -  More than 4 weeks since prior and no concurrent participation in another experimental
             drug study

          -  More than 30 days since prior non-approved or investigational drugs