Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach
NCT ID: NCT00003237
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
1998-06-22
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of paclitaxel and cisplatin, given after surgery in treating patients with cancer of the esophagus or stomach.
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Detailed Description
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OUTLINE: Patients undergo esophagogastrectomies within 4-12 weeks prior to the study. Patients receive intravenous paclitaxel over 3 hours on day 1, followed by intravenous cisplatin. Treatment is repeated every 21 days for 4 courses. Patients exhibiting disease recurrence or unacceptable toxic effects are removed from the study. Patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and then every 12 months thereafter.
PROJECTED ACCRUAL: A total of 55 patients will be accrued within 16 months.
Conditions
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Study Design
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TREATMENT
Interventions
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cisplatin
paclitaxel
surgical procedure
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-1 Life Expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 120,000/mm3 Hepatic: SGOT no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 2 times ULN Renal: Creatinine within institutional normal limits Cardiovascular: No New York Heart Association class III or IV heart disease No symptomatic coronary artery disease No myocardial infarction within 6 months No clinically significant conduction system abnormalities such as second or third degree heart block or bundle branch block Neurologic: No symptomatic peripheral neuropathy No psychosis Other: Not pregnant or nursing Effective contraceptive method must be used by fertile patients No significant hearing loss No concurrent uncontrolled infection or medical illness No concurrent malignancies within 3 years, except: Nonmelanoma skin cancer Carcinoma in situ of the cervix No history of allergy to drugs containing cremophor No hypersensitivity to E. coli derived proteins
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Eastern Cooperative Oncology Group
Principal Investigators
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Arlene A. Forastiere, MD
Role: STUDY_CHAIR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Central Illinois
Springfield, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Veterans Affairs Medical Center - New York
New York, New York, United States
Kaplan Cancer Center
New York, New York, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
Allegheny University Hospitals- Hahnemann
Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - San Juan
San Juan, , Puerto Rico
Pretoria Academic Hospital
Pretoria, , South Africa
Countries
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References
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Armanios M, Xu R, Forastiere AA, Haller DG, Kugler JW, Benson AB 3rd; Eastern Cooperative Oncology Group. Adjuvant chemotherapy for resected adenocarcinoma of the esophagus, gastro-esophageal junction, and cardia: phase II trial (E8296) of the Eastern Cooperative Oncology Group. J Clin Oncol. 2004 Nov 15;22(22):4495-9. doi: 10.1200/JCO.2004.06.533.
Other Identifiers
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E-8296
Identifier Type: -
Identifier Source: secondary_id
CDR0000066109
Identifier Type: -
Identifier Source: org_study_id
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