Phase II Study of Cetuximab and Bevacizumab in Esophageal Carcinoma That Failed First Line Therapy
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab, cetuximab
- Conditions
- Esophageal Carcinoma
- Sponsor
- Emory University
- Primary Endpoint
- Progression-free survival
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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.
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.
Investigators
Nabil F. Saba
Principal Investigator
Emory University
Eligibility Criteria
Inclusion Criteria
- •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.
- •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)
Exclusion Criteria
- •I. Disease-specific Exclusions
- •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.
- •II. General Medical Exclusions
- •Subjects meeting any of the following criteria are ineligible for study entry:
Arms & Interventions
A
Single arm treatment with combination of cetuximab and bevacizumab
Intervention: Bevacizumab, cetuximab
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: Every 3 months
Secondary Outcomes
- Response rate(Every 3 months)