Study of Nab-Paclitaxel and Ramucirumab as Second-line Treatment for Patients With Metastatic Gastroesophageal Cancer
Condition: Gastroesophageal Cancer
Intervention: nab-paclitaxel; ramucirumab
Intervention description: nab-paclitaxel 125 mg/m^2 IV; Ramucirumab 8 mg/kg IV
Intervention MeSH terms: Paclitaxel; Ramucirumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gastroesophageal adenocarcinoma; nab-paclitaxel; Abraxane; ramucirumab; Cyramza; GE junction

Summary:

      The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab
      (Cyramza®) are effective when used in combination for treating patients with metastatic
      gastroesophageal cancer who have either progressed or not responded to prior therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologically confirmed metastatic adenocarcinoma of the esophagus, GE
             junction, or stomach who progressed on one prior line of chemotherapy in the
             metastatic setting.

          2. Measurable disease as measured by Response Evaluation Criteria in Solid Tumors
             (RECIST) criteria Version 1.1.

          3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

          4. Adequate hematologic, renal, and hepatic functions

          5. Patients must have < Grade 2 pre-existing peripheral neuropathy (per National Cancer
             Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v 4.03)

          6. Life expectancy > 3 months

        Exclusion Criteria:

          1. Patients who have received any other investigational agents, chemotherapy, biologic
             therapy, or radiation therapy within the 28 days prior to Day 1 of the study. For
             investigational, chemotherapy, or biologic therapy, patients will be allowed on study
             if five half-lives or greater have elapsed since last dose of drug or 28 days,
             whichever is shorter.

          2. Patients with prior taxane chemotherapy or agents which act by primary anti-angiogenic
             mechanisms.

          3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, or psychiatric illness/social situations that would limit safety or
             compliance with study requirements or may interfere with the interpretation of the
             results.

          4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to study initiation, or anticipation of need for major surgical procedure during
             the course of the study.

          5. Evidence or history of uncontrolled hypertension, proteinuria, non-healing wound,
             ulcer, bone fracture, hemoptysis, valvular disease, abdominal fistula, GI perforation,
             intra-abdominal abscess, bleeding diathesis or coagulopathy that would exclude
             patients from treatment with anti-angiogenesis agents.

          6. Therapeutic anticoagulation with coumarin-derivatives will not be permitted. However,
             a maximum daily dose of 1 mg will be permitted for port line patency. Anticoagulation
             with low molecular weight heparin or anti-Factor Xa agents will be allowed.

          7. Patients with other concurrent severe and/or uncontrolled medical disease which could
             compromise safety of treatment as so judged by treating physician (i.e., severely
             impaired lung function, severe infection, ventricular arrhythmias active ischemic
             heart disease, known active vasculitis of any cause, chronic liver or renal disease).