Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma
Condition: Gastroesophageal Adenocarcinoma; Adenocarcinoma of the Distal Esophagus; Adenocarcinomas of the Gastroesophageal Junction; Adenocarcinoma of the Proximal Stomach
MeSH terms: Adenocarcinoma
Intervention: Panitumumab; Paclitaxel; Carboplatin; 5FU
Intervention description: Panitumumab 9mg/kg on Days 1, 22, and 43; Paclitaxel 200mg/m2 on Days 1 and 22; Carboplatin AUC=6 on Days 1 and 22; 5FU 225mg/m2/day on Days 1-15 and 22-36
Intervention MeSH terms: Paclitaxel; Carboplatin; Fluorouracil; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, Phase II, single-stage study evaluating the use of panitumumab,
      paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal
      adenocarcinoma. The expectation is that this combination will both increase potential overall
      survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease
      potential surgical mortality by eliminating pre-operative radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-proven adenocarcinoma of the distal esophagus, gastroesophageal junction, or
             proximal stomach (within 5cm of gastroesophageal junction)

          -  No prior treatment for this disease

          -  AJCC (American Joint Committee on Cancer) clinical stage II to IVA, potentially
             resectable disease

          -  Measurable disease per RECIST 1.0 criteria

          -  Medically fit for surgery; surgical consultation is encouraged prior to initiation of
             treatment

          -  ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1

          -  Male or female; aged equal to or greater than 18 years

          -  Life expectancy of greater than 3 months

          -  Good organ, metabolic, bone marrow, and pulmonary function as specified in the
             protocol

          -  Functioning central venous access device prior to treatment initiation

          -  Women of childbearing potential and men must agree to use adequate contraception prior
             to study entry and for at least 6 months following the last administration of
             panitumumab

          -  Ability to understand and the willingness to sign a written IRB (Institutional Review
             Board) approved informed consent

        Exclusion Criteria:

          -  Prior treatment for this disease

          -  History of another primary cancer except curatively treated in situ cervical cancer,
             curatively resected nonmelanoma skin cancer, or other primary solid tumor curatively
             treated with no active disease present and no treatment administered for at least 5
             years prior to enrollment

          -  History or known presence of central nervous system metastases

          -  History of allergic reactions attributed to compounds similar chemical or biologic
             composition to panitumumab, paclitaxel, carboplatin, or 5FU

          -  Prior anti-EGFr-antibody therapy or treatment with small molecule EGFr inhibitors

          -  Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved
             proteins/antibodies within 30 days prior to enrollment

          -  Chronic use of immunosuppressive agents with the exception of corticosteroids

          -  Any investigational agent or therapy within 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
             study requirements

          -  History of interstitial lung disease, e.g., pneumonitis or pulmonary fibrosis or any
             evidence of interstitial lung disease on baseline chest CT scan

          -  History of any medical or psychiatric condition or laboratory abnormality that in the
             opinion of the investigator may increase the risks associated with study participation
             or investigational product(s) administration or may interfere with the interpretation
             of the results

          -  Unwilling or unable to comply with study requirements

          -  Female who tests positive for serum or urine pregnancy test or is breast feeding

          -  Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus,
             acute or chronic active hepatitis B infection

          -  Major surgery within 28 days or minor surgery within 7 days prior to treatment.
             Placement of a central venous access device less than one day prior to treatment start

          -  Male or female of childbearing potential (women who are post-menopausal less than 52
             weeks, not surgically sterilized, or not abstinent) not consenting to use adequate
             contraception prior to study entry and for at least 6 months following the last
             administration of panitumumab

          -  Arterial ischemic event (myocardial infarction, stroke) within 3 months prior to
             enrollment

          -  Ongoing therapeutic anticoagulation