Panitumumab in Cetuximab Refractory KRAS Wild-Type Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: panitumumab
Intervention description: Panitumumab is administered intravenously (IV) by an infusion pump through a peripheral line or indwelling catheter using a 0.2 or 0.22-micron in-line filter infusion set-up over 1 hour 15 minutes. The starting panitumumab dose is 6 mg/kg administered every 14 days for as long as patients are on study without evidence of disease progression or demonstrating intolerance to treatment. The total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose will be calculated based on the subject's actual body weight at each visit. Panitumumab will be diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution (normal saline solution, supplied by the site). The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: panitumumab; cetuximab; KRAS wild-type

Summary:

      The purpose of this research study is to learn whether panitumumab helps treat colorectal
      cancer in participants who have not responded to treatment with cetuximab. Panitumumab is a
      human monoclonal antibody. Antibodies are proteins that recognize a foreign substance in the
      body and then attach themselves to it making it exposed to destruction. Panitumumab attaches
      itself to a protein on cancer cells called "epidermal growth factor receptor" or EGFR. EGFR
      helps cancer cells to grow, and blocking EGFR helps prevent cancer cells from growing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and
             measurable disease by RECIST criteria on CT or MRI

          -  Treated with cetuximab as part of their last treatment regimen for at least 4 weeks
             and must have been taken off cetuximab therapy for disease progression. Patients may
             or may not have been treated with 5-FU (5-Fluorouracil), oxaliplatin, irinotecan and
             bevacizumab. There is no maximal number of pre-existing treatment regimens. At least 2
             weeks must have elapsed between previous anticancer therapy and the start of treatment
             on protocol, AND resolution of any skin rash related to prior treatment with epidermal
             growth factor receptor inhibitor

          -  ECOG (Eastern Cooperative Oncology Group) Performance Status 0, 1 or 2

          -  Life expectancy of greater than 3 months

          -  Normal organ, metabolic, and marrow function as defined in the protocol

          -  A wild-type tumor K-RAS gene (Kirsten rat sarcoma viral oncogene homolog) as
             determined by sanger sequencing of exon 2 from tumor DNA

          -  18 years of age or older

        Exclusion Criteria:

          -  History of untreated and or progression central nervous system metastases

          -  History of another primary cancer except: curatively treated in situ cervical cancer
             or breast; curatively resected non-melanoma skin cancer; other primary solid tumor
             curatively treated with no known active disease present and no treatment administered
             for 3 years or more prior to enrollment

          -  Intolerance to cetuximab leading to drug discontinuation due to rash, GI toxicity, or
             other grade 3 or 4 toxicities

          -  Radiotherapy < 14 days prior to enrollment

          -  Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved
             proteins/antibodies < 14 days before enrollment

          -  Subjects requiring chronic use of immunosuppressive agents

          -  Any investigational agent or therapy 30 days prior to enrollment

          -  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 compliance with
             any study requirements

          -  History of interstitial lung disease

          -  Women who test positive for serum or urine pregnancy test or who are breast feeding