Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach

Gastric Cancer Clinical Trial

Official title:

Phase II Trial of Post-Operative Adjuvant Paclitaxel + Cisplatin in Patients With Adenocarcinoma of the Esophagus, Gastro-Esophageal Junction or Cardia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003237
• Other study ID #: CDR0000066109
• Secondary ID: E-8296
• Status: Completed
• Phase: Phase 2
• Start date: June 22, 1998

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill more tumor cells. 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.

Description:

OBJECTIVES: I. Evaluate the disease free survival and overall survival of patients with adenocarcinoma of the esophagus, gastroesophageal junction, or cardia receiving post-operative adjuvant paclitaxel plus cisplatin. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the esophagus, gastroesophageal junction or cardia T2N1, T3 any N, T4 any N, and negative margins Proximal and distal margins of resection must be negative No metastases Must be within 4-12 weeks from date of surgery and clinically without evidence of local-regional or distant recurrence 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• cisplatin

• paclitaxel

Procedure:
• surgical procedure

Locations

Country	Name	City	State
Puerto Rico	Veterans Affairs Medical Center - San Juan	San Juan
South Africa	Pretoria Academic Hospital	Pretoria
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	New England Medical Center Hospital	Boston	Massachusetts
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Lakeside)	Chicago	Illinois
United States	Ireland Cancer Center	Cleveland	Ohio
United States	CCOP - Evanston	Evanston	Illinois
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Veterans Affairs Medical Center - Madison	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	Kaplan Cancer Center	New York	New York
United States	Veterans Affairs Medical Center - New York	New York	New York
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Allegheny University Hospitals- Hahnemann	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Central Illinois	Springfield	Illinois
United States	CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico,  South Africa, 

References & Publications (1)

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 Coo — View Citation