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Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

Thank you

Trial Information

Oxaliplatin (NSC-266046) Plus Protracted Infusion 5-Fluorouracil And Radiation For Potentially Curable Esophageal Cancer: A Phase II Trial With Molecular Correlates


OBJECTIVES:

Primary

- Determine the pathologic complete response probability in patients with stage II or III
adenocarcinoma of the esophagus or gastroesophageal junction treated with neoadjuvant
oxaliplatin, fluorouracil, and radiotherapy followed by definitive surgical resection.

Secondary

- Determine the frequency and severity of toxic effects associated with this neoadjuvant
regimen in these patients.

- Determine the overall survival and progression-free survival of patients treated with
this regimen.

Exploratory Analyses (subject to funding availability)

- Correlate, preliminarily, initial messenger ribonucleic acid (mRNA) levels of the genes
for thymidylate synthase (TS), γ-glutamyl transpeptidase (γGT), γ-glutamyl cysteine
(γ-GCS), DNA excision repair cross-complementing (ERCC-1), and xeroderma pigmentosum
(XPA) with response and survival of patients treated with this regimen.

- Correlate, preliminarily, the mRNA levels of TS, γGT, γ-GCS, ERCC-1, and XPA before and
after treatment with this regimen with survival of these patients.

- Correlate, preliminarily, specific genetic polymorphisms of TS and ERCC-1 with tumor
response and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

- Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin IV over 2 hours on days 1,
15, and 29 and fluorouracil (5-FU) IV continuously on days 8-43. Beginning on day 8,
patients also undergo radiotherapy once daily, 5 days a week, for 5 weeks.

- Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks
after completion of chemoradiotherapy.

- Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive
chemotherapy comprising oxaliplatin IV over 2 hours on days 1, 15, and 29 and 5-FU IV
continuously on days 1-36.

Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 45-85 patients will be accrued for this study within 17-21
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary adenocarcinoma of the thoracic esophagus or
gastroesophageal junction

- No recurrent disease

- Primary esophageal tumor at least 20 cm below the incisors (if < 26 cm below the
incisors, a bronchoscopy must be performed and cytology must be negative)

- Esophageal disease confined to esophagus and peri-esophageal soft tissue

- Gastroesophageal junction disease extending ≤ 2 cm into the gastric cardia

- Clinical stage II or III disease by CT scan or MRI

- If no esophageal mass is detected by these methods, esophageal endoscopic
ultrasound is required to determine stage

- Positron-emission tomography scan is required to confirm stage

- Measurable or non-measurable disease by x-ray, scanning, or physical examination

- No celiac axis nodes ≥ 1.5 cm

- Measurable regional lymph nodes ≥ 1.5 cm at stations 2-10=N1 OR subdiaphragmatic
lymph nodes at stations 15-19 ≤ 1.5 cm by CT scan or MRI allowed

- Palpable supraclavicular lymph nodes must be free of metastatic esophageal
cancer by biopsy

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- White blood cell (WBC) count ≥ 3,000/mm^3

- Hemoglobin ≥ 10.0 g/dL (transfusion allowed)

Hepatic

- Albumin ≥ 3 g/dL

- Bilirubin normal

Renal

- Creatinine ≤ 1.5 times upper limit of normal

Cardiovascular

- No myocardial infarction or cerebrovascular event within the past 6 months

Pulmonary

- No active pneumonia or inflammatory lung infiltrate

Other

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No peripheral neuropathy ≥ grade 2

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for esophageal cancer

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for esophageal cancer

- No concurrent intensity-modulated radiotherapy

Surgery

- No prior surgical resection or attempted surgical resection of esophageal cancer

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological Complete Response

Outcome Description:

Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.

Outcome Time Frame:

10-16 weeks after beginning study treatment

Safety Issue:

No

Principal Investigator

Lawrence P. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Desert Regional Medical Center Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000371963

NCT ID:

NCT00086996

Start Date:

September 2004

Completion Date:

August 2011

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • stage II esophageal cancer
  • stage III esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
LDS HospitalSalt Lake City, Utah  84143
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Scott and White HospitalTemple, Texas  76508
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
University of California Davis Cancer CenterSacramento, California  95817
Wesley Medical CenterWichita, Kansas  67214
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Eden Medical CenterCastro Valley, California  94546
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Valley Care Medical CenterPleasanton, California  94588
Poudre Valley HospitalFort Collins, Colorado  80524
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Mecosta County Medical CenterBig Rapids, Michigan  49307
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Highland General HospitalOakland, California  94602
Northeast Georgia Medical CenterGainesville, Georgia  30501
Randolph HospitalAsheboro, North Carolina  27203
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Annie Penn Cancer CenterReidsville, North Carolina  27320
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Clinton Memorial HospitalWilmington, Ohio  45177
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Southwest Virginia Regional Cancer Center at Wellmonth HealthNorton, Virginia  24273
St. Joseph Cancer CenterBellingham, Washington  98225
Columbia Basin HematologyKennewick, Washington  99336
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
St. John's Regional Medical CenterJoplin, Missouri  64804
Providence Cancer CenterAnchorage, Alaska  99508
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Rockwood Clinic Cancer Treatment CenterSpokane, Washington  99204-2967
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
Boston University Cancer Research CenterBoston, Massachusetts  02118
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Desert Regional Medical Center Comprehensive Cancer CenterPalm Springs, California  92262
East Bay Radiation Oncology CenterCastro Valley, California  94546
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
Valley Medical Oncology Consultants - PleasantonPleasanton, California  94588
AnMed Cancer CenterAnderson, South Carolina  29621
Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California  94546
Valley Medical OncologyFremont, California  94538
Olathe Cancer CenterOlathe, Kansas  66061
Frontier Cancer CenterGreat Falls, Montana  59405