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

NCT ID: NCT00006038

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29
• Study Completion Date: 2003-02-28

Brief 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.

Detailed Description

OBJECTIVES: I. Determine the efficacy and toxicity of neoadjuvant cisplatin, fluorouracil, and docetaxel, and postoperative intraperitoneal floxuridine and leucovorin calcium in patients with locally advanced adenocarcinoma of the stomach or gastroesophageal junction. II. Determine whether molecular markers, including thymidylate synthase, excision repair cross complementing gene, and tubulin isoform 4B, for sensitivity to fluorouracil, cisplatin, and docetaxel, respectively, are predictive of outcome (disease free survival and overall survival) in these patients. III. Determine the quality of life of these patients treated with this regimen.

OUTLINE: During weeks 1 and 4, patients receive docetaxel IV over 1 hour followed by cisplatin IV over 30-60 minutes on day 1, and fluorouracil IV continuously on days 1-5. During weeks 6-8, patients undergo radical subtotal or total gastrectomy with a D2 lymph node dissection followed by percutaneous placement of an intraperitoneal port device. Beginning within 5 days after resection, patients with clear margins receive floxuridine and leucovorin calcium intraperitoneally on days 1-3 during weeks 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to beginning study, prior to surgery, then monthly for 3 months beginning after completion of study therapy, then every 3 months through year 2, and then every 6 months through year 3. Patients are followed monthly for 3 months, then every 3 months through year 2, and then every 6 months though year 3.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2.5 years.

Conditions

Esophageal Cancer; Gastric Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

docetaxel

Intervention Type: DRUG

floxuridine

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

David Paul Kelsen, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000068053

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G00-1813

Identifier Type: -

Identifier Source: secondary_id

99-066

Identifier Type: -

Identifier Source: org_study_id