Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer
Condition: Colorectal Cancer; Neoplasm Metastasis
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Intervention: Cetuximab; Oxaliplatin; Capecitabine
Intervention description: 500 mg/m2, IV every two weeks; 85 mg/m2, IV, q 2 weeks; 2500 mg, po bid x 7 days every two weeks
Intervention MeSH terms: Capecitabine; Oxaliplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Previously untreated metastatic colorectal cancer; Metastatic Colorectal Cancer; combined therapy; biologics therapy; antibody; chemotherapy; EGFR; epidermal growth factor receptor

Summary:

      This is a Phase II, open label, non-randomized study in subjects with histologically
      confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who
      have not received prior chemotherapy for metastatic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have signed an approved informed consent.

          -  Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum,
             with KRAS wild type on mutational analysis.

          -  No prior chemotherapy for metastatic disease (chemotherapy naive). Prior adjuvant
             therapy with 5FU/LV or IFL (irinotecan, fluorouracilis, and leucovorin (folinic acid))
             permitted if completed at least six months prior to entering this study.

          -  Measurable disease by RECIST criteria as defined in Section 3.3.1.

          -  Subjects for whom tumor tissue is available for IHC ( Immunohistochemistry) testing
             for EGFR expression.

          -  ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1.

          -  Recovery in full from any previous surgical procedure.

          -  Expected survival greater than 12 weeks.

          -  Subjects at least 18 years of age.

          -  Women of childbearing potential (WOCBP) must be using an adequate method of
             contraception to avoid pregnancy throughout the study and for up to 4 weeks after the
             study in such a manner that the risk of pregnancy is minimized. WOCBP must have a
             negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent
             units of HCG) within 72 hours prior to the start of study medication.

          -  Adequate hematologic function defined by an absolute neutrophil count (ANC) >
             1,500/mm3, a platelet count > 100,000/mm3 .

          -  Adequate hepatic function defined by a total bilirubin level no greater than 2.0 times
             the upper limit of normal (ULN) and AST (Aspartate Aminotransferase) and ALT (alanine
             transaminase) levels noo greater than 2.5 times the ULN (AST and ALT levels no greater
             than 5 times the ULN in the presence of liver metastases).

          -  Adequate renal function defined by a serum creatinine level no greater than 1.5 times
             the ULN.

        Exclusion Criteria:

          -  WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
             the entire study period and for up to 4 weeks after the study.

          -  Women who are pregnant or breastfeeding.

          -  Women with a positive pregnancy test on enrollment or prior to study drug
             administration.

          -  Sexually active fertile men not using effective birth control if their partners are
             women of child-bearing potential.

          -  Subjects with > Grade 1 neuropathy.

          -  Any active or uncontrolled infection.

          -  History of myocardial infarction within the previous six months or current clinical
             evidence of congestive heart failure.

          -  History of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of
             the cervix) unless in complete remission and off all therapy for that cancer for at
             least 5 years.

          -  Central nervous system metastases.

          -  Pregnant or lactating women. Men and women of reproductive potential must agree to use
             an effective contraceptive method.

          -  Medical or psychiatric disorders that would interfere with informed consent or make
             them a poor risk for participation in this trial.

          -  Prior allergic reaction to chimerized or murine monoclonal antibody therapy or
             documented presence of human anti-mouse antibodies (HAMA).

          -  Subjects receiving a prior investigational agent within 30 days.

          -  Prior therapy with oxaliplatin, cetuximab, or prior therapy that targets the EGF (
             epidermal growth factor) pathway.

          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
             treatment of either a psychiatric or physical (e.g., infectious disease) illness must
             not be enrolled into this study.

          -  Mutation in the KRAS gene