Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Condition(s) targeted: Esophageal Cancer

Intervention: cisplatin (Drug); filgrastim (Drug); fluorouracil (Drug); paclitaxel (Drug); pegfilgrastim (Drug); biological therapy (Procedure); chemotherapy (Procedure); colony-stimulating factor therapy (Procedure); conventional surgery (Procedure); cytokine therapy (Procedure); radiation therapy (Procedure); surgery (Procedure)

Phase: Phase 2

Status: No longer recruiting

Sponsored by: Radiation Therapy Oncology Group

Official(s) and/or principal investigator(s):
Stephen G. Swisher, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center

RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells

PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.

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

Study design: Interventional, Treatment, Open Label

Primary outcome:

Overall survival rate at 1 year

Frequency of major (grade 4) acute toxicities

Frequency of patients with persistent or recurrent disease eligible for surgical salvage resection

Detailed description: 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.

Minimum age: 18 Years. Gender(s): Both.

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

CCOP - Bay Area Tumor Institute, Oakland, California 94609, United States

J.C. Robinson, M.D. Regional Cancer Center, San Pablo, California 94806, United States

Providence Holy Cross Cancer Center, Mission Hills, California 91346-9600, United States

Providence Saint Joseph Medical Center - Burbank, Burbank, California 91505, United States

Saint Rose Hospital, Hayward, California 94545, United States

Summit Medical Center, Oakland, California 94609, United States

Valley Care Medical Center, Pleasanton, California 94588, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado 80045, United States

Hospital of Saint Raphael, New Haven, Connecticut 06511, United States

Baptist-South Miami Regional Cancer Program, Miami, Florida 33176, United States

Gulf Coast Cancer Treatment Center, Panama City, Florida 32405, United States

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States

Mount Sinai Hospital Medical Center, Chicago, Illinois 60608, United States

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana 46107, United States

Wendt Regional Cancer Center at Finley Hospital, Dubuque, Iowa 52001, United States

CCOP - Ochsner, New Orleans, Louisiana 70121, United States

Ochsner Clinic of Baton Rouge, Baton Rouge, Louisiana 708169990, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

Foote Hospital, Jackson, Michigan 49201, United States

Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States

Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan 49431, United States

Green Bay Oncology, Limited - Iron Mountain, Iron Mountain, Michigan 49801, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan 48123-2500, United States

Seton Cancer Institute - Saginaw, Saginaw, Michigan 48601, United States

Sparrow Regional Cancer Center, Lansing, Michigan 48909, United States

St. John Macomb Hospital, Warren, Michigan 48093, United States

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan 48106-0995, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

Fairview Ridges Hospital, Burnsville, Minnesota 55337, United States

Fairview Southdale Hospital, Edina, Minnesota 55435, United States

Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota 55422-2900, United States

Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota 55432, United States

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota 55433, United States

Park Nicollet Health Services, St. Louis Park, Minnesota 55416, United States

Ridgeview Medical Center, Waconia, Minnesota 55387, United States

United Hospital, St. Paul, Minnesota 55102, United States

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota 55407, United States

Hattiesburg Clinic, P.A., Hattiesburg, Mississippi 39401, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65802, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri 65807, United States

Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri 63110, United States

St. John's Regional Health Center, Springfield, Missouri 65804, United States

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada 89102, United States

Booker Cancer Center at Riverview Medical Center, Red Bank, New Jersey 07701, United States

Community Regional Cancer Center at Community Medical Center, Toms River, New Jersey 08755, United States

Fox Chase Virtua Health Cancer Program - Marlton, Marlton, New Jersey 08053, United States

Monmouth Medical Center, Long Branch, New Jersey 07740-6395, United States

Albuquerque Regional Medical Center at Lovelace Sandia Health System, Albuquerque, New Mexico 87102, United States

University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico 87131-5636, United States

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

Rutherford Hospital, Rutherfordton, North Carolina 28139, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina 27534, United States

Wayne Radiation Oncology, Goldsboro, North Carolina 27534, United States

Wilmed Radiation Oncology Services, Wilson, North Carolina 27893, United States

Akron City Hospital, Akron, Ohio 44309-2090, United States

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem, Ohio 44460, United States

Cancer Treatment Center, Wooster, Ohio 44691, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

Charles F. Kettering Memorial Hospital, Kettering, Ohio 45429, United States

David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio 45409, United States

Good Samaritan Hospital, Dayton, Ohio 45406, United States

Grandview Hospital, Dayton, Ohio 45405, United States

Middletown Regional Hospital, Middletown, Ohio 45044, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio 45385, United States

Samaritan North Cancer Care Center, Dayton, Ohio 45415, United States

UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio 45373-1300, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States

Albert Einstein Cancer Center, Philadelphia, Pennsylvania 19141, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania 19010, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill, Pennsylvania 19026, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111-2497, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States

Lankenau Cancer Center at Lankenau Hospital, Wynnewood, Pennsylvania 19096, United States

Paoli Memorial Hospital, Paoli, Pennsylvania 19301-1792, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson, South Carolina 29621, United States

M.D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

Cottonwood Hospital Medical Center, Murray, Utah 84107, United States

Dixie Regional Medical Center - East Campus, Saint George, Utah 84770, United States

Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah 84112, United States

LDS Hospital, Salt Lake City, Utah 84143, United States

McKay-Dee Hospital Center, Ogden, Utah 84403, United States

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City, Utah 84106, United States

Utah Valley Regional Medical Center - Provo, Provo, Utah 84604, United States

Schiffler Cancer Center at Wheeling Hospital, Wheeling, West Virginia 26003, United States

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin 54143, United States

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin 54154, United States

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin 54235, United States

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin 54303, United States

Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay, Wisconsin 54301-3526, United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin 54601, United States

St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin 54303, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-3508, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: September 2003
Last updated: March 20, 2007