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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393068
Recruitment Status : Completed
First Posted : October 26, 2006
Results First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

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.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Erlotinib Drug: Bevacizumab Drug: Paclitaxel Drug: Carboplatin Drug: 5-FU Procedure: Radiation therapy Procedure: Surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Concurrent Chemotherapy/Radiation Therapy Plus Bevacizumab/Erlotinib in the Treatment of Localized Esophageal Cancer
Study Start Date : February 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Erlotinib

Arm Intervention/treatment
Experimental: 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.

Drug: Erlotinib
Erlotinib
Other Name: Tarceva

Drug: Bevacizumab
Bevacizumab
Other Name: Avastin

Drug: Paclitaxel
Paclitaxel
Other Name: Taxol

Drug: Carboplatin
Carboplatin
Other Name: Paraplatin

Drug: 5-FU
5-FU
Other Name: Fluorouracil

Procedure: Radiation therapy
Radiation therapy

Procedure: Surgery
Surgery




Primary Outcome Measures :
  1. Pathologic Complete Response (pCR) Rate [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 32 months ]
  2. Overall Survival [ Time Frame: 32 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393068


Locations
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United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, New Jersey
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, United States, 07960
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Investigators
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Principal Investigator: John D Hainsworth, MD SCRI Development Innovations, LLC
Publications:
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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00393068    
Other Study ID Numbers: SCRI GI 91
First Posted: October 26, 2006    Key Record Dates
Results First Posted: November 30, 2012
Last Update Posted: November 30, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Bevacizumab
Carboplatin
Fluorouracil
Erlotinib Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors