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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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