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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003237

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

1.8

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer	Drug: cisplatin Drug: paclitaxel Procedure: surgical procedure	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 1998

Actual Primary Completion Date :

Oct 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611
2	Veterans Affairs Medical Center - Chicago (Lakeside)	Chicago	Illinois	United States	60611
3	CCOP - Evanston	Evanston	Illinois	United States	60201
4	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
5	CCOP - Central Illinois	Springfield	Illinois	United States	62526
6	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
7	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
8	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
9	New England Medical Center Hospital	Boston	Massachusetts	United States	02111
10	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
11	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
12	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
13	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
14	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
15	Veterans Affairs Medical Center - New York	New York	New York	United States	10010
16	Kaplan Cancer Center	New York	New York	United States	10016
17	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
18	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
19	CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma	United States	74136
20	Allegheny University Hospitals- Hahnemann	Philadelphia	Pennsylvania	United States	19102-1192
21	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104
22	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
23	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15213
24	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
25	Veterans Affairs Medical Center - Madison	Madison	Wisconsin	United States	53705
26	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792
27	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
28	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin	United States	53295
29	Veterans Affairs Medical Center - San Juan	San Juan		Puerto Rico	00927-5800
30	Pretoria Academic Hospital	Pretoria		South Africa	0001