Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Intervention: bevacizumab; cetuximab; Oxaliplatin; Capecitabine
Intervention description: Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle; Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 every 21 days; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle
Intervention MeSH terms: Bevacizumab; Cetuximab; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic; colorectal; cancer; initial therapy

Summary:

      The purpose of this study is to determine the objective response rate of patients with
      previously untreated metastatic colorectal cancer treated with the combination of cetuximab,
      capecitabine, and oxaliplatin with out without bevacizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  measurable metastatic adenocarcinoma of the colon or rectum

          -  no prior systemic therapy for metastatic disease

          -  adjuvant therapy must have been completed >/=12 months prior to recurrence, prior
             radiotherapy permitted but must have been completed > 6 months prior to study entry

          -  must have tumor tissue available for EGFR and thymidine phosphorylase evaluation

          -  ECOG PS 0-1

          -  age >/= 18

          -  adequate organ function: WBC>/=3,000, ANC >/=1,500, platelets>/= 100,000, total
             bilirubin </= 1.5X ULN, AST&ALT </= 2.5X ULN, create clearance >/= 50mL/min

          -  negative pregnancy test w/in 72 hours of treatment for women of child bearing
             potential

          -  ability to understand and willing to sign written ICF

          -  able to swallow and absorb oral medication

        Exclusion Criteria:

          -  medical or psychiatric condition which would potentially pose risk to patient by
             participation (i.e. but not limited to:uncontrolled hypertension, MI w/in 6 months,CNS
             disease, pregnancy or nursing)

          -  history of neoplasm (other than non-metastatic skin cancer or carcinoma in situ of
             cervix) w/in 5 years

          -  surgical procedure (not including closed biopsy or access port placement), open
             biopsy, significant traumatic injury w/in 28 days of registration or anticipation of
             need for surgical procedure while on study, fine needle aspiration or core biopsy w/in
             7 days of registration

          -  urine protein:creatinine ration >/=1.0 at screening

          -  evidence of bleeding diathesis or coagulopathy (in absence of anticoagulation)

          -  prior severe infusion reaction to MAB or allergic reaction to capecitabine or
             oxaliplatin

          -  underlying neuropathy >/= grade 2

          -  TIA or CVA w/in 6 months