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
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Fort Myers, Florida, Forenede Stater, 33901
- Florida Cancer Specialists
-
Jacksonville, Florida, Forenede Stater, 32256
- Integrated Community Oncology Network
-
-
Georgia
-
Gainesville, Georgia, Forenede Stater, 30501
- Northeast Georgia Medical Center
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40207
- Consultants in Blood Disorders and Cancer
-
-
New Jersey
-
Morristown, New Jersey, Forenede Stater, 07960
- Hematology Oncology Associates of Northern NJ
-
-
Ohio
-
Canton, Ohio, Forenede Stater, 44710
- Aultman Hospital
-
Cincinnati, Ohio, Forenede Stater, 45242
- Oncology Hematology Care
-
-
Tennessee
-
Chattanooga, Tennessee, Forenede Stater, 37404
- Chattanooga Oncology Hematology Associates
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Nashville, Tennessee, Forenede Stater, 37023
- Tennessee Oncology, PLLC
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Kirurgi
Bevacizumab
Andre navne:
Carboplatin
Andre navne:
Paclitaxel
Andre navne:
Erlotinib
Andre navne:
5-FU
Andre navne:
Radiation therapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pathologic Complete Response (pCR) Rate
Tidsramme: 18 months
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: 32 months
|
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.
|
32 months
|
|
Progression-Free Survival
Tidsramme: 36 months
|
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.
|
36 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: John D Hainsworth, MD, SCRI Development Innovations, LLC
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Esophageale neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Proteinkinasehæmmere
- Carboplatin
- Paclitaxel
- Erlotinib hydrochlorid
- Fluorouracil
- Bevacizumab
Andre undersøgelses-id-numre
- SCRI GI 91
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