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A Phase II Trial of Erlotinib and Avastin in Previously Treated Patients With Cancer of the Esophagus or Gastroesophageal Junction

Phase 2
18 Years
Not Enrolling
Esophageal Neoplasms, Esophageal Diseases

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Trial Information

A Phase II Trial of Erlotinib and Avastin in Previously Treated Patients With Cancer of the Esophagus or Gastroesophageal Junction

We postulate that the addition of bevacizumab may increase the efficacy of erlotinib in
patients with metastatic esophageal cancer, without adding significant toxicity. The
non-overlapping toxicity profiles may allow the administration of the maximum tolerated
doses for both agents without additive toxicities with the goal of demonstrating synergistic
clinical activity. This combination has been previously tested in two studies for other
malignancies with good tolerance and encouraging results.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

Until the patient has progressive disease

Safety Issue:


Principal Investigator

Daniel Morgensztern, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

January 2009

Related Keywords:

  • Esophageal Neoplasms
  • Esophageal Diseases
  • Esophagus
  • Esophagogastric Junction
  • Avastin
  • Bevacizumab
  • Erlotinib
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110