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

Phase 2
18 Years
Not Enrolling
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

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

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

PROJECTED ACCRUAL: A total of 55 patients will be accrued within 16 months.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Arlene A. Forastiere, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 1998

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • adenocarcinoma of the stomach
  • adenocarcinoma of the esophagus
  • Adenocarcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



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Kaplan Cancer Center New York, New York  10016
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
New England Medical Center Hospital Boston, Massachusetts  02111
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Northern New Jersey Hackensack, New Jersey  07601
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Medical College of Wisconsin Milwaukee, Wisconsin  53226
CCOP - Central Illinois Springfield, Illinois  62526
Allegheny University Hospitals- Hahnemann Philadelphia, Pennsylvania  19102-1192
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
Veterans Affairs Medical Center - New York New York, New York  10010
Veterans Affairs Medical Center - Chicago (Lakeside) Chicago, Illinois  60611
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136