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

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00393068
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Erlotinib
  • Bevacizumab — DRUG
    Bevacizumab
  • Paclitaxel — DRUG
    Paclitaxel
  • Carboplatin — DRUG
    Carboplatin
  • 5-FU — DRUG
    5-FU
  • Radiation therapy — PROCEDURE
    Radiation therapy
  • Surgery — PROCEDURE
    Surgery

Study Details

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.

Key Dates

First listed
Oct 26, 2006
Start date
Feb 28, 2007
Status verified
Feb 2022
Primary completion
Sep 30, 2009
Completion
Aug 31, 2011

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Pathologic Complete Response (pCR) Rate [ Time Frame: 18 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Integrated Community Oncology NetworkJacksonvilleFlorida32256-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Consultants in Blood Disorders and CancerLouisvilleKentucky40207-
Hematology Oncology Associates of Northern NJMorristownNew Jersey07960-
Aultman HospitalCantonOhio44710-
Oncology Hematology CareCincinnatiOhio45242-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37023-

Find similar trials in Fort Myers, FL

By condition
Esophageal cancer
By specialty
OncologyGI oncology
By research site
Florida Cancer Specialists· Fort Myers, FLIntegrated Community Oncology Network· Jacksonville, FLNortheast Georgia Medical Center· Gainesville, GAConsultants in Blood Disorders and Cancer· Louisville, KYHematology Oncology Associates of Northern NJ· Morristown, NJAultman Hospital· Canton, OH

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