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
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer
Both
Esophageal Cancer
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 Hospital | Akron, Ohio 44304 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Foote Hospital | Jackson, Michigan 49201 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
| United Hospital | St. Paul, Minnesota 55102 |
| Ridgeview Medical Center | Waconia, Minnesota 55387 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| SUNY Downstate Medical Center | Brooklyn, New York 11203 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
| Fox Chase Virtua Health Cancer Program - Marlton | Marlton, New Jersey 08053 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Cottonwood Hospital Medical Center | Murray, Utah 84107 |
| McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| Summit Medical Center | Oakland, California 94609 |
| Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Saint Rose Hospital | Hayward, California 94545 |
| Valley Care Medical Center | Pleasanton, California 94588 |
| J.C. Robinson, M.D. Regional Cancer Center | San Pablo, California 94806 |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
| Ochsner Clinic of Baton Rouge | Baton Rouge, Louisiana 708169990 |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
| Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
| Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
| Hattiesburg Clinic, P.A. | Hattiesburg, Mississippi 39401 |
| Booker Cancer Center at Riverview Medical Center | Red Bank, New Jersey 07701 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
| Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
| Providence Holy Cross Cancer Center | Mission Hills, California 91346-9600 |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque, Iowa 52001 |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
| Hospital of Saint Raphael | New Haven, Connecticut 06511 |
| Albuquerque Regional Medical Center at Lovelace Sandia Health System | Albuquerque, New Mexico 87102 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Wilmed Radiation Oncology Services | Wilson, North Carolina 27893 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Community Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
| Mount Sinai Hospital Medical Center | Chicago, Illinois 60608 |
