Erlotinib and Avastin in Patients With Cancer of the Esophagus or Gastroesophageal Junction
Condition: Esophageal Neoplasms; Esophageal Diseases
MeSH terms: Esophageal Neoplasms; Esophageal Diseases
Intervention: Erlotinib; Avastin
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esophagus; Esophagogastric Junction; Avastin; Bevacizumab; Erlotinib

Summary:

      Determine the time to progression for the combination of erlotinib and bevacizumab in
      patients with previously treated metastatic cancer of the esophagus or gastroesophageal
      junction
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven adenocarcinoma or squamous cell carcinoma of the esophagus or
             gastroesophageal junction.

          -  Metastatic or advanced inoperable disease previously treated with one prior
             chemotherapy regimen

          -  Age greater than 18 years.

          -  Performance status ECOG 0 to 1.

          -  Adequate hepatic and renal function, defined as:

               -  Serum creatinine <= 3.0 mg/dL;

               -  Creatinine clearance >= 45 mL/min.

               -  Bilirubin <= 1.5 x institutional normal;

               -  ALT/AST <= 3 x institutional normal.

          -  Patients must have measurable disease. Measurable disease is defined as at least one
             lesion that can be accurately measured in at least one dimension. The longest diameter
             of measurable lesions must be >= 20 mm with conventional techniques or >= 10 mm with
             spiral CT scan. Lesions that are not considered measurable include: bone lesions,
             leptomeningeal disease, brain lesions, ascites, pericardial or pleural effusion, and
             tumors situated in a previously irradiated area.

          -  Use of effective means of contraception for both male and female patients with
             child-bearing potential.

          -  A 1 month wash-out period is required for all patients entering this study from a
             previous treatment regimen

        Exclusion Criteria:

          -  Previous use of anti-EGFR or anti-VEGF therapy.

          -  Previous history of cancer. The patient with a prior malignancy is eligible for this
             study only if the patient meets the following criteria for a cancer survivor. A cancer
             survivor is eligible provided the following criteria are met: (1) patient has
             undergone potentially curative therapy for all prior malignancies, (2) patients have
             been considered disease free for at least 5 years (with the exception of basal cell or
             squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to day 0; or anticipation of the need for major surgical procedure during the
             course of the study. (In the case of high risk procedures such as liver resection,
             thoracotomy, or neurosurgery, it is recommended that patient delay treatment with
             chemotherapy for at least 6 weeks and with bevacizumab at least 8 weeks after
             surgery).

          -  Radiation therapy within the last 2 weeks.

          -  Presence of central nervous system or brain metastases at any time.

          -  Serious, non-healing wound, ulcer, or bone fracture

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to day 0; and/or minor surgical procedures such as fine needle
             aspiration or core biopsies within 7 days prior to day 0.

          -  Presence of coagulopathy or clinical history of significant hematemesis, melena, or
             hemoptysis related to the diagnosis of esophageal cancer.

          -  Previous history of deep venous thrombosis or thromboembolic disease.

          -  Urine protein/urine creatinine ratio ≥ 1.0 at screening.

          -  Pregnant or lactating.

          -  Unstable angina or history of myocardial infarction within the last 6 months.

          -  History of stroke within the last 6 months.

          -  Uncontrolled hypertension with blood pressure persistently > 150/100 mmHg despite
             optimal antihypertensive therapy.

          -  Clinically significant peripheral vascular disease.

          -  Congestive heart failure with New York Heart Association grades III or IV (see
             appendix B).

          -  Inability to complete the study and follow-up procedures.

          -  Participation in therapeutic clinical trials or currently receiving other
             investigational treatment(s) within 30 days prior to enrollment