Combination Chemotherapy Before and After Surgery in Treating Patients With Stomach Cancer

July 1, 2013 updated by: Memorial Sloan Kettering Cancer Center

A PHASE II TRIAL OF NEOADJUVANT CISPLATIN-FLUOROURACIL CHEMOTHERAPY, SURGERY, AND INTRAPERITONEAL (IP) FLOXURIDINE (FUdR) PLUS LEUCOVORIN IN PATIENTS WITH GASTRIC CANCER

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 giving them in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy before and after surgery in treating patients with high-risk stomach cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Evaluate the efficacy and toxicity of neoadjuvant cisplatin/fluorouracil (CDDP/5-FU) followed by surgery followed by adjuvant intraperitoneal floxuridine/leucovorin in patients with high-risk gastric cancer. II. Assess the quality of life and cost-benefit ratio associated with this treatment. III. Evaluate the sensitivity, specificity, and overall staging accuracy of laparoscopy with or without laparoscopic ultrasound in predicting the resectability rate (with and without neoadjuvant CDDP/5-FU), response to chemotherapy, and accuracy when compared to pathologic findings. IV. Correlate the presence of mutated vs. wild-type p53 suppressor oncogenes in endoscopic biopsies and resected tumor specimens with clinical outcome (defined as downstaging, failure pattern, and disease-free and overall survival) in patients treated with and without neoadjuvant CDDP/5-FU.

OUTLINE: The following acronyms are used: CDDP Cisplatin, NSC-119875 CF Leucovorin calcium, NSC-3590 5-FU Fluorouracil, NSC-19893 FUDR Floxuridine, NSC-27640 2-Drug Combination Chemotherapy followed by Surgery followed by Single-Agent Chemotherapy with Drug Modulation. CDDP/5-FU; followed by total or subtotal radical gastrectomy with D2 dissection; followed by FUDR; with CF.

PROJECTED ACCRUAL: A total of 50 patients will be entered over 2-2.5 years.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Microscopically confirmed adenocarcinoma of the stomach or gastroesophageal junction Reviewed by Department of Pathology of participating institution Stage II-IV (T2, N1-2, M0 or T3-4, any N, M0) by physical exam, CT, and laparoscopy Potentially curable by surgery Suspected sites of metastasis proven M0 prior to entry

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 4,000 Platelets at least 150,000 Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min BUN no greater than 30 mg/dL Cardiovascular: No NYHA class III/IV status No active angina No myocardial infarction within 6 months No significant ventricular arrhythmia requiring medication No clinically significant conduction system abnormality Other: No serious intercurrent infection No nonmalignant medical illness that is uncontrolled or precludes study participation No psychiatric disorder that precludes informed consent No clinically significant auditory impairment No second malignancy within 5 years except: Basal cell skin cancer Carcinoma in situ of the cervix No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David Paul Kelsen, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1996

Primary Completion (Actual)

January 1, 2001

Study Completion (Actual)

January 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 23, 2004

First Posted (Estimate)

August 24, 2004

Study Record Updates

Last Update Posted (Estimate)

July 3, 2013

Last Update Submitted That Met QC Criteria

July 1, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96-027
  • CDR0000064831 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-H96-0916

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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