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A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

Thank you

Trial Information

A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus


OBJECTIVES:

- Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil
followed by chemoradiotherapy and possible surgical salvage in patients with resectable
locally advanced carcinoma of the esophagus or gastroesophageal junction.

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

- Determine the treatment-related toxicity of this regimen in these patients.

- Determine the tolerance to surgical salvage in patients treated with this regimen.

- Determine the morbidity and mortality of surgical salvage in patients treated with this
regimen.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours
beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel
IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and
34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence
of unacceptable toxicity.

- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV
continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients
concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82,
85-89, and 92-96.

Patients with residual or recurrent esophageal disease 4-6 weeks after completion of
chemoradiotherapy may undergo salvage esophagectomy.

Patients are followed periodically.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus
or gastroesophageal junction

- Primary (non-recurrent) disease

- Amenable to resection

- Stage greater than T1, N0 by endoscopic ultrasound

- Must be entirely confined to the esophagus or gastroesophageal junction and
periesophageal soft tissue

- Tumor may not extend more than 2 cm into the stomach

- No multiple primary carcinomas of the esophagus

- No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus

- No evidence of disseminated cancer

- Suggestion of liver metastases by positron emission tomography must be proven
negative by biopsy or other imaging studies

- Palpable supraclavicular nodes must be negative for cancer by biopsy

- Bronchoscopy required for lesions less than 26 cm from the incisors to exclude
tracheoesophageal fistula or invasion

- No celiac adenopathy greater than 2 cm

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 150,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic

- Not specified

Renal

- Creatinine no greater than 1.5 mg/dL AND/OR

- Creatinine clearance at least 65 mL/min

- Calcium no greater than 11 mg/dL

Cardiovascular

- No uncontrolled heart disease

- No uncontrolled hypertension

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to comprehend study requirements and considered likely to comply with study
parameters

- No other malignancy within the past 5 years except curable nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No uncontrolled diabetes

- No hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- More than 5 years since prior systemic chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior chest or upper abdomen radiotherapy

Surgery

- No prior esophageal or gastric surgery

Other

- No concurrent photodynamic therapy

- No other concurrent investigational agents for esophageal carcinoma

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival rate at 1 year

Safety Issue:

No

Principal Investigator

Stephen G. Swisher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000306455

NCT ID:

NCT00069953

Start Date:

September 2003

Completion Date:

Related Keywords:

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

Name

Location

Akron City HospitalAkron, Ohio  44304
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
CCOP - OchsnerNew Orleans, Louisiana  70121
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
LDS HospitalSalt Lake City, Utah  84143
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Summit Medical CenterOakland, California  94609
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Saint Rose HospitalHayward, California  94545
Valley Care Medical CenterPleasanton, California  94588
J.C. Robinson, M.D. Regional Cancer CenterSan Pablo, California  94806
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Ochsner Clinic of Baton RougeBaton Rouge, Louisiana  708169990
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Hattiesburg Clinic, P.A.Hattiesburg, Mississippi  39401
Booker Cancer Center at Riverview Medical CenterRed Bank, New Jersey  07701
Wayne Radiation OncologyGoldsboro, North Carolina  27534
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
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
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Providence Holy Cross Cancer CenterMission Hills, California  91346-9600
Wendt Regional Cancer Center at Finley HospitalDubuque, Iowa  52001
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
Hospital of Saint RaphaelNew Haven, Connecticut  06511
Albuquerque Regional Medical Center at Lovelace Sandia Health SystemAlbuquerque, New Mexico  87102
Rutherford HospitalRutherfordton, North Carolina  28139
Wilmed Radiation Oncology ServicesWilson, North Carolina  27893
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Community Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
Mount Sinai Hospital Medical CenterChicago, Illinois  60608