Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer
NCT ID: NCT00393068
Last Updated: 2022-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2007-02-28
2011-08-31
Brief Summary
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Side effects (toxicity) information will also be collected.
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Detailed Description
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Prior 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Prior 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.
Erlotinib
Erlotinib
Bevacizumab
Bevacizumab
Paclitaxel
Paclitaxel
Carboplatin
Carboplatin
5-FU
5-FU
Radiation therapy
Radiation therapy
Surgery
Surgery
Interventions
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Erlotinib
Erlotinib
Bevacizumab
Bevacizumab
Paclitaxel
Paclitaxel
Carboplatin
Carboplatin
5-FU
5-FU
Radiation therapy
Radiation therapy
Surgery
Surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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John D Hainsworth, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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Florida Cancer Specialists
Fort Myers, Florida, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, United States
Aultman Hospital
Canton, Ohio, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Countries
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References
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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.
Other Identifiers
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SCRI GI 91
Identifier Type: -
Identifier Source: org_study_id
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