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Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Bevacizumab
Paclitaxel
Carboplatin
5-FU
Radiation therapy
Surgery
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Sites / Locations

  • Florida Cancer Specialists
  • Integrated Community Oncology Network
  • Northeast Georgia Medical Center
  • Consultants in Blood Disorders and Cancer
  • Hematology Oncology Associates of Northern NJ
  • Aultman Hospital
  • Oncology Hematology Care
  • Chattanooga Oncology Hematology Associates
  • Tennessee Oncology, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival
Overall Survival (OS) is defined as the time interval from the start of treatment until death. Patients who remained alive were censored at the date of their last tumor assessment.
Progression-Free Survival
Progression-free survival (PFS) was defined as the interval from the date of first treatment until the date of disease progression or death, whichever occurred first. Patients who did not progress were censored at the date of their last tumor assessment.

Full Information

First Posted
October 25, 2006
Last Updated
February 18, 2022
Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00393068
Brief Title
Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer
Official Title
A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Carboplatin
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
Fluorouracil
Intervention Description
5-FU
Intervention Type
Procedure
Intervention Name(s)
Radiation therapy
Intervention Description
Radiation therapy
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery
Primary Outcome Measure Information:
Title
Pathologic Complete Response (pCR) Rate
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival (OS) is defined as the time interval from the start of treatment until death. Patients who remained alive were censored at the date of their last tumor assessment.
Time Frame
32 months
Title
Progression-Free Survival
Description
Progression-free survival (PFS) was defined as the interval from the date of first treatment until the date of disease progression or death, whichever occurred first. Patients who did not progress were censored at the date of their last tumor assessment.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Integrated Community Oncology Network
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Consultants in Blood Disorders and Cancer
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Hematology Oncology Associates of Northern NJ
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22895283
Citation
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.
Results Reference
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Learn more about this trial

Chemotherapy, Radiation Therapy and Immunotherapy Prior to Surgery in Operable Esophageal Cancer

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