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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
N/A
Not Enrolling
Both
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
thereafter.

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
Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Arlene A. Forastiere, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066109

NCT ID:

NCT00003237

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

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Kaplan Cancer CenterNew York, New York  10016
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - Central IllinoisSpringfield, Illinois  62526
Allegheny University Hospitals- HahnemannPhiladelphia, Pennsylvania  19102-1192
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
Veterans Affairs Medical Center - New YorkNew York, New York  10010
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136