Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer

• Status: Completed
• Trial end date: 2009-06-01
• 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. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells.

PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Floxuridine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven, previously untreated gastric cancer

• Stage IB, II, III, or IV (T3-4, N0 OR any T, N1-2, M0)

• No metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4000/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin less than 2 mg/dL

• SGOT/SGPT no greater than 2 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 3 times ULN

• PT, aPTT, and TT normal

• No Gilbert's disease

Renal:

• BUN no greater than 30 mg/dL

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No myocardial infarction within the past 3 months

• No congestive heart failure requiring therapy

Other:

• No other invasive malignancy in the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

• No active or uncontrolled infection

• HIV negative

• No other severe concurrent disease

• No psychiatric disorders that would preclude compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for gastric cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for gastric cancer

Surgery:

• No prior surgery for gastric cancer

• No emergent need for surgery for gastrointestinal obstruction, perforation, or hemorrhage