Bevacizumab Plus Capecitabine (Xeloda) in Patients With Untreated Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Capecitabine (Xeloda); Bevacizumab
Intervention description: 1000mg/m^2 administered orally twice daily for two weeks followed by one week rest period; 7.5 mg/kg IV will be administered every 3 weeks
Intervention MeSH terms: Bevacizumab; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of the bevacizumab and
      capecitabine combination in frail patients with untreated metastatic colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven adenocarcinoma of the colon at first diagnosis

          -  Stage IV disease, with at least one measurable lesion according to the RECIST criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status 2

          -  No prior chemotherapy for metastatic colorectal cancer

          -  Prior adjuvant chemotherapy is permitted.

          -  At least 28 days since prior surgery

          -  If female of childbearing potential, pregnancy test is negative and willing to use
             effective contraception while on treatment and for at least 3 months thereafter.

          -  Required laboratory values:

               -  Absolute neutrophil count > 1.5 x 10^9/L

               -  Hemoglobin > 9.0 g/dL

               -  Platelet count > 100 x 10^9/L

               -  Creatinine < 2.0 mg/dL

               -  Total bilirubin < 1.5 x upper limit of normal (ULN) (Patients with documented
                  Gilbert's syndrome are eligible.)

               -  Alkaline phosphatase and AST/ALT within the following parameters. In determining
                  eligibility, the more abnormal of the two values (AST or ALT) should be used:

                    -  Alkaline phosphate and AST/ALT < or = ULN

                    -  Alkaline phosphate > 1x but < or = 2.5x and AST/ALT < or = ULN

                    -  Alkaline phosphate > 2.5x but < or = 5x and AST/ALT < or = ULN

                    -  Alkaline phosphate < or = ULN and AST/ALT > 1x but < or = 1.5x

                    -  Alkaline phosphate > 1x but < or = 2.5 x and AST/ALT > 1x but < or = 1.5x

                    -  Alkaline phosphate < or = ULN and AST/ALT > 1x but < or = 2.5x

        Exclusion Criteria:

          -  Prior chemotherapy for metastatic colorectal cancer

          -  Prior treatment with an anti-angiogenic agent

          -  Concurrent therapy with any other non-protocol anti-cancer therapy

          -  Current or prior history of central nervous system or brain metastases

          -  Presence of neuropathy > grade 2 (NCI-Common Toxicity Criteria (CTC) version 3.0) at
             baseline

          -  Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically
             significant (> grade 2) peripheral vascular disease

          -  History of any other malignancy within the past 5 years, with the exception of
             non-melanoma skin cancer or carcinoma-in-situ of the cervix

          -  Clinically significant cardiovascular disease (e.g., blood pressure [BP] > 150/100,
             myocardial infarction or stroke within the past 6 months, unstable angina, New York
             Heart Association (NYHA) Grade II or greater congestive heart failure, or serious
             cardiac arrhythmia requiring medication

          -  Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal
             condition increasing the risk of perforation; history of abdominal fistula,
             gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to
             beginning therapy

          -  Active infection requiring parenteral antimicrobials

          -  The presence of any other medical or psychiatric disorder that, in the opinion of the
             treating physician, would contraindicate the use of the drugs in this protocol or
             place the subject at undue risk for treatment complications

          -  Inability to comply with the study protocol or follow-up procedures

          -  Pregnancy or lactation

          -  A history of a severe hypersensitivity reaction to bevacizumab, or capecitabine or
             other drugs formulated with polysorbate 80.

          -  Evidence of bleeding diathesis or coagulopathy.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, or anticipation of the need for a major surgical procedure during the
             course of the study; minor surgical procedure, fine needle aspiration or core biopsy
             within 7 days prior to Day 0

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study other than a Genentech-sponsored
             bevacizumab cancer study

          -  Unstable angina

          -  Urine protein creatinine ratio greater than or equal to 1.

          -  Therapeutic anticoagulation with oral anticoagulation medications, specifically
             coumarins