Study of Cetuximab and Bevacizumab in Cancer of the Esophagus After Failure of Patient's First Therapy
NCT ID: NCT00636298
Last Updated: 2013-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2008-10-31
2012-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A
Single arm treatment with combination of cetuximab and bevacizumab
Bevacizumab, cetuximab
Cetuximab - 400 mg/m2 loading, then 250 mg/m2 weekly
Bevacizumab - 10 mg/kg every 2 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bevacizumab, cetuximab
Cetuximab - 400 mg/m2 loading, then 250 mg/m2 weekly
Bevacizumab - 10 mg/kg every 2 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nabil F. Saba
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nabil Saba, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Winship Cancer Institute
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6037
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00006037
Identifier Type: -
Identifier Source: org_study_id