CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater
Condition: Gastrointestinal Cancer
MeSH terms: Adenocarcinoma; Gastrointestinal Neoplasms
Intervention: Panitumumab
Intervention description: Starting Dose Level: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ampulla of Vater; Adenocarcinoma of the small bowel; Metastatic; Kirsten rat sarcoma; KRAS; Capecitabine; Xeloda; Oxaliplatin; Eloxatin; CAPOX; Panitumumab; Vectibix

Summary:

      The goal of this clinical research study is to learn if panitumumab can help to control
      advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be
      studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically confirmed adenocarcinoma of the small bowel or
             ampulla of Vater that is either unresectable or metastatic.

          2. Adequate tumor tissue available for KRAS mutational analysis or known KRAS wild-type
             status.

          3. Prior progression on or intolerance to treatment with a fluoropyrimidine and
             oxaliplatin. Recurrence of disease within 6 months from the completion of adjuvant
             therapy with both a fluoropyrimidine and oxaliplatin is considered progression.

          4. Patients must have measurable disease as per the revised Response Evaluation Criteria
             In Solid Tumors (RECIST) criteria (Version 1.1).

          5. If radiation was previously received, the measurable disease must be outside the
             previous radiation field, unless this area has demonstrated evidence of radiographic
             growth.

          6. A minimum of 2 weeks must have elapsed from completion of any prior chemotherapy or
             radiotherapy or surgery and the start date of study therapy.

          7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 2.

          8. Adequate organ function including: a) Absolute neutrophil count (ANC) =/>1,000/ul; b)
             Platelets =/>75,000/ul; c) Total bilirubin =/< 1.5 x ULN; in patients with known
             Gilbert's syndrome direct bilirubin =/<1.5 x ULN will be used as organ function
             criteria, instead of total bilirubin; d) AST (SGOT)/ALT (SGPT) < 3 x ULN; e)
             Creatinine <2 x ULN.

          9. Negative urine or serum pregnancy test in women with childbearing potential (defined
             as not post-menopausal for 12 months or no previous surgical sterilization), within
             one week prior to initiation of treatment.

         10. The effects of panitumumab on the developing fetus are unknown. For this reason, women
             of childbearing potential and men must agree to use adequate contraception (hormonal
             or barrier method of birth control) prior to study entry, for the duration of study
             participation, and for six months following the completion of therapy. Should a woman
             become pregnant while participating in this study, she should inform her treating
             physician immediately.

         11. Patients must sign an Informed Consent and Authorization indicating that they are
             aware of the investigational nature of this study and the known risks involved.

         12. Magnesium level =/> lower limit of normal.

        Exclusion Criteria:

          1. Prior anti-epidermal growth factor receptor antibody therapy (eg. panitumumab or
             cetuximab) or prior small molecule anti-epidermal growth factor receptor therapy (eg.
             erlotinib) for adenocarcinoma of the small bowel or ampulla of Vater.

          2. Patients may not be receiving any other investigational agents nor have received any
             investigational drug 30 days prior to enrollment.

          3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit adherence with
             study requirements.

          4. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung.

          5. Because there is an unknown but potential risk for adverse events in nursing infants
             secondary to treatment of the mother with panitumumab, breast feeding must be
             discontinued.

          6. Age <18 years. Because no dosing or adverse event data are currently available on the
             use of panitumumab in patients <18 years of age, children are excluded from this
             study.