Overview

Combination Chemotherapy Followed by Surgery and Intraperitoneal Chemotherapy in Treating Patients With Locally Advanced Stomach Cancer

Status:
Completed
Trial end date:
2003-02-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery and intraperitoneal chemotherapy in treating patients who have locally advanced stomach cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Calcium
Cisplatin
Docetaxel
Floxuridine
Fluorouracil
Leucovorin
Levoleucovorin
Criteria
DISEASE CHARACTERISTICS: Histologically proven locally advanced adenocarcinoma of the
stomach or gastroesophageal (GE) junction that is potentially curable by surgery Patients
with tumors involving the GE junction must have the bulk of their disease in the stomach No
tumors of the distal esophagus or GE junction that extend less than 2 cm into the stomach
Tumor stage T2, N1-2, M0 OR T3-4, any N, M0 by physical exam, CT scan, and laparoscopy

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least
150,000/mm3 Hepatic: Bilirubin less than 2 mg/dL SGOT and/or SGPT no greater than 2.5 times
upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR Alkaline
phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN Ineligible
if SGOT and SGPT greater than 1.5 times ULN AND alkaline phosphatase greater than 2.5 times
ULN Renal: Blood urea nitrogen no greater than 30 mg/dL Creatinine no greater than 1.5
mg/dL AND/OR Creatinine clearance greater than 50 mL/min Cardiovascular: No New York Heart
Association class III or IV heart disease No active angina or myocardial infarction within
the past 6 months No history of significant ventricular arrhythmia requiring medication
with antiarrhythmics or significant conduction system abnormality Other: No clinically
significant auditory impairment No worse than grade 2 preexisting peripheral neuropathy No
other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in
situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception No serious concurrent infection or nonmalignant illness that is
uncontrolled or whose control may be jeopardized by complications of study therapy No
psychiatric disorder that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
See Disease Characteristics