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

NCT00636298 | Withdrawn Phase 2 DMC

• 2 other identifiers: IRB000060376037
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Carcinoma

Keywords

esophageal carcinoma; cancer of the esophagus; locally advanced or metastatic esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Every 3 months

Secondary Outcomes (1)

• Response rate

  Every 3 months

Study Arms (1)

A

EXPERIMENTAL

Single arm treatment with combination of cetuximab and bevacizumab

Drug: Bevacizumab, cetuximab

Interventions

Bevacizumab, cetuximab DRUG

Cetuximab - 400 mg/m2 loading, then 250 mg/m2 weekly Bevacizumab - 10 mg/kg every 2 weeks

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed squamous cell carcinoma or esophageal adenocarcinoma.
• The disease must be recurrent after first line systemic therapy, with or without radiation, with or without surgery.
• Patients must be at least 1 month from prior chemotherapy or radiation therapy.
• ECOG performance status ≤ 1 (Karnofsky \> 60%)
• Life expectancy of greater than 12 weeks.
• Age \> 18.
• 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)
• 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.
• Women of childbearing potential must have a negative pregnancy test.
• Ability to understand and willingness to sign a written informed consent document.

You may not qualify if:

• All histologic types other than squamous cell carcinoma or adenocarcinoma.
• Patients currently receiving other investigational agents, or who have received cetuximab previously.
• Patients with known brain metastases.
• History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to Cetuximab or Bevacizumab.
• 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.
• Patients who are felt to be poorly compliant.
• Women who are breast-feeding.
• Subjects meeting any of the following criteria are ineligible for study entry:
• Inability to comply with study and/or follow-up procedures.
• Life expectancy of less than 12 weeks.
• 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.
• Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \>100 mmHg on antihypertensive medications).
• Any prior history of hypertensive crisis or hypertensive encephalopathy.
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 6 months prior to study enrollment.

Sponsors & Collaborators

• Emory University: lead
• Genentech, Inc.: collaborator

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Bevacizumab; Cetuximab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Nabil Saba, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 14, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2012
• Last Updated: November 19, 2013

Record last verified: 2013-11