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Study of Cetuximab and Bevacizumab in Cancer of the Esophagus After Failure of Patient's First Therapy

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: NCT00636298
Recruitment Status : Withdrawn (lack of funding)
First Posted : March 14, 2008
Last Update Posted : November 19, 2013
Genentech, Inc.
Information provided by (Responsible Party):
Nabil F. Saba, Emory University

Brief Summary:
The purpose of this study is to test the drug bevacizumab in combination with cetuximab. Because this combination has not been tested in cancer patients before, results will be analyzed to see what effects the combination of bevacizumab with cetuximab has on esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Carcinoma Drug: Bevacizumab, cetuximab Phase 2

Detailed Description:

Cancer of the esophagus often has a poor outcome since many patients have advanced disease when they are diagnosed. The average survival rate after five years has increased from 4% in the 1970s to around 14% currently.

Surgery to remove the tumor or treatment with radiotherapy alone has led to disappointing results for patients. Chemotherapy has some activity in patients with advanced disease, although responses are usually short. New strategies are trying to combine these three treatment approaches to improve survival for these patients.

This study will test the combination of cetuximab and bevacizumab in patients with locally advanced esophageal cancer. This is a group of patients with usually poor outcomes from treatment with surgery, radiotherapy or chemotherapy alone. Scientifically, this study will help assess the value in combining these two different types of drug.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Cetuximab and Bevacizumab in Esophageal Carcinoma That Failed First Line Therapy
Study Start Date : October 2008
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Single arm treatment with combination of cetuximab and bevacizumab
Drug: Bevacizumab, cetuximab

Cetuximab - 400 mg/m2 loading, then 250 mg/m2 weekly

Bevacizumab - 10 mg/kg every 2 weeks

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Every 3 months ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: Every 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  1. Patients must have histologically or cytologically confirmed squamous cell carcinoma or esophageal adenocarcinoma.
  2. The disease must be recurrent after first line systemic therapy, with or without radiation, with or without surgery.
  3. Patients must be at least 1 month from prior chemotherapy or radiation therapy.
  4. ECOG performance status ≤ 1 (Karnofsky > 60%)
  5. Life expectancy of greater than 12 weeks.
  6. Age > 18.
  7. Patients must have normal bone marrow and other organ function or defined below:

    • Absolute neutrophil count, > 1, 500/μL
    • Platelet counts, > 100, 00/μL

      _ Hemoglobin, > 8.0 gm/dL-

    • Creatinine(< 1.5mg/dL)
  8. No significant intercurrent medical illness (including NYHA class II, III or IV heart disease, significant arrhythmias requiring medication, symptomatic coronary artery disease, myocardial infarction within the previous 6 months.
  9. Women of childbearing potential must have a negative pregnancy test.
  10. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

I. Disease-specific Exclusions

  1. All histologic types other than squamous cell carcinoma or adenocarcinoma.
  2. Patients currently receiving other investigational agents, or who have received cetuximab previously.
  3. Patients with known brain metastases.
  4. History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to Cetuximab or Bevacizumab.
  5. Patients with history of any other malignancy (except non-melanomatous skin cancer or CIS of cervix) are ineligible unless a period of 5 years has lapsed since treatment of the previous cancer and the patient has remained continuously disease free.
  6. Patients who are felt to be poorly compliant.
  7. Women who are breast-feeding.

II. General Medical Exclusions

Subjects meeting any of the following criteria are ineligible for study entry:

  1. Inability to comply with study and/or follow-up procedures.
  2. Life expectancy of less than 12 weeks.
  3. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.

III. Bevacizumab-Specific Exclusions

  1. Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure >100 mmHg on antihypertensive medications).
  2. Any prior history of hypertensive crisis or hypertensive encephalopathy.
  3. New York Heart Association (NYHA) Grade II or greater congestive heart failure
  4. History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
  5. History of stroke or transient ischemic attack within 6 months prior to study enrollment.
  6. Known CNS disease.
  7. Significant vascular disease (e.g., aortic aneurysm, aortic dissection).
  8. Symptomatic peripheral vascular disease.
  9. Evidence of bleeding diathesis or coagulopathy.
  10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study.
  11. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
  12. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
  13. Serious, non-healing wound, ulcer, or bone fracture.
  14. Proteinuria at screening as demonstrated by either

    • Urine protein: creatinine (UPC) ratio ≥ 1.0 at screening OR
    • Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible)
  15. Known hypersensitivity to any component of bevacizumab.
  16. Pregnant (positive pregnancy test) or lactating. Use of effective means of contraception (men and women) in subjects of child-bearing potential.
  17. History of myocardial infarction or unstable angina within 6 months of study 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): NCT00636298

Sponsors and Collaborators
Emory University
Genentech, Inc.
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Principal Investigator: Nabil Saba, MD Emory University Winship Cancer Institute

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Responsible Party: Nabil F. Saba, Principal Investigator, Emory University Identifier: NCT00636298    
Other Study ID Numbers: IRB00006037
6037 ( Other Identifier: Other )
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Keywords provided by Nabil F. Saba, Emory University:
esophageal carcinoma
cancer of the esophagus
locally advanced or metastatic esophageal cancer
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors