Trial record 5 of 5 for:    4938153 [PUBMED-IDS]

Erlotinib and Avastin in Patients With Cancer of the Esophagus or Gastroesophageal Junction (OSI3650)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442507
Recruitment Status : Terminated (Slow accrual)
First Posted : March 2, 2007
Results First Posted : July 3, 2015
Last Update Posted : July 24, 2015
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Esophageal Diseases Drug: Erlotinib Drug: Avastin Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Erlotinib and Avastin in Previously Treated Patients With Cancer of the Esophagus or Gastroesophageal Junction
Study Start Date : March 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
Drug: Erlotinib
Other Name: Avastin

Drug: Avastin

Primary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: Median follow-up for TTP 6 weeks (6-18 weeks) ]
    • TTP is defined as the time from initiation of treatment to the date of documented progression.
    • The median of TTP with 95% confidence interval will be presented.
    • Progressive disease (target lesions) is defined as at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
    • Progressive disease (non-target lesions) is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions.

Secondary Outcome Measures :
  1. Overall Survival Rate (OS) [ Time Frame: Median followup time from completion of treatment 325.5 days (44-401 days) ]
    OS is defined as the time from initiation of treatment to the date of death for any reason.

  2. Response Rate (Complete Response (CR), Partial Response (PR), and CR+PR) [ Time Frame: Median follow-up for response 6 weeks (6-18 weeks) ]
    • CR = disappearance of all target lesions
    • PR = at least a 30% decrease in the sum of the LD of the target lesions taking as reference the baseline sum LD.

  3. Incidence and Severity of Toxicities [ Time Frame: Median follow-up time for toxicities 72 days (72 days-156 days) ]
    Grade 3 and higher toxicities using CTCAE Version 3.0.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442507

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Daniel Morgensztern, M.D. Washington University School of Medicine

Additional Information:

Responsible Party: Washington University School of Medicine Identifier: NCT00442507     History of Changes
Other Study ID Numbers: 06-1105
First Posted: March 2, 2007    Key Record Dates
Results First Posted: July 3, 2015
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Washington University School of Medicine:
Esophagogastric Junction

Additional relevant MeSH terms:
Esophageal Neoplasms
Esophageal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors