Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer
A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer
1 other identifier
interventional
62
1 country
9
Brief Summary
The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer. Side effects (toxicity) information will also be collected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2007
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2006
CompletedFirst Posted
Study publicly available on registry
October 26, 2006
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
November 30, 2012
CompletedMarch 2, 2022
February 1, 2022
2.6 years
October 25, 2006
August 22, 2012
February 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Pathologic Complete Response (pCR) Rate
pCR was defined as no residual viable cancer found at the primary site or regional lymph nodes upon pathologic review of the surgical specimen for patients who went to surgical resection.
18 months
Secondary Outcomes (2)
Overall Survival
32 months
Progression-Free Survival
36 months
Study Arms (1)
Treatment
EXPERIMENTALPrior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks). Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.
Interventions
Eligibility Criteria
You may qualify if:
- Clinically confirmed esophageal or gastroesophageal junction cancer stage I, II or III
- No prior treatment for esophageal cancer
- Must be surgical candidate based on stage and location of disease
- Measurable or evaluable disease
- Able to be up and perform self care
- Adequate liver, renal function and bone marrow function
- Patients will have to have a central venous access device placed
- Able to give written informed consent.
- Age 18 or older
You may not qualify if:
- Stage IV disease
- Prior cancer treatment for advanced cancer in the last 5 years
- Pregnant or lactating women
- History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
- History of neurological disease
- Recent history of blood in the sputum or vomitus
- Non-healing wounds, ulcer or long bone fractures
- History of bleeding problems or coagulation problems
- History of abdominal fistula, gi perforation or intrabdominal abscess within 6 months
- History of uncontrolled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
Study Sites (9)
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, 07960, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Related Publications (1)
Bendell JC, Meluch A, Peyton J, Rubin M, Waterhouse D, Webb C, Burris HA 3rd, Hainsworth JD. A phase II trial of preoperative concurrent chemotherapy/radiation therapy plus bevacizumab/erlotinib in the treatment of localized esophageal cancer. Clin Adv Hematol Oncol. 2012 Jul;10(7):430-7.
PMID: 22895283BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Johanna C. Bendell, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
John D Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2006
First Posted
October 26, 2006
Study Start
February 1, 2007
Primary Completion
September 1, 2009
Study Completion
August 1, 2011
Last Updated
March 2, 2022
Results First Posted
November 30, 2012
Record last verified: 2022-02