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Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004103
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 6, 2011
National Cancer Institute (NCI)
Information provided by:
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: cisplatin Drug: floxuridine Drug: irinotecan hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Detailed Description:


  • Determine the complete and partial response rates and time to treatment failure in patients with advanced gastric cancer treated with neoadjuvant irinotecan and cisplatin followed by surgery then intraperitoneal floxuridine and cisplatin.
  • Determine the rate of potentially curative surgery in patients receiving this regimen.
  • Determine the toxicity and tolerance of this regimen in these patients.

OUTLINE: Patients receive cisplatin IV and irinotecan IV once a week for 4 weeks. This course is repeated 2 weeks later.

Patients who achieve complete or partial remission or stable disease undergo resection 4 weeks after the last chemotherapy dose.

Patients with no residual macroscopic disease begin adjuvant intraperitoneal (IP) chemotherapy 1 week after surgery. Chemotherapy consists of floxuridine IP over 30 minutes on days 1-3 and days 22-24 and cisplatin IP on days 3 and 24.

PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Systemic Therapy With CPT-11 (Camptosar HCl) and Cisplatin in Patients With Advanced Gastric Cancer to be Followed by Surgical Resection and Postoperative Intraperitoneal Chemotherapy
Study Start Date : July 1998
Actual Primary Completion Date : March 2007
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven, previously untreated gastric cancer

    • Stage IB, II, III, or IV (T3-4, N0 OR any T, N1-2, M0)
    • No metastases



  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • Not specified


  • WBC at least 4000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • 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


  • BUN no greater than 30 mg/dL
  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min


  • No myocardial infarction within the past 3 months
  • No congestive heart failure requiring therapy


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy for gastric cancer

Endocrine therapy:

  • Not specified


  • No prior radiotherapy for gastric cancer


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004103

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United States, New York
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
National Cancer Institute (NCI)
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Study Chair: Elliot Newman, MD NYU Langone Health
Publications of Results:
Layout table for additonal information Identifier: NCT00004103    
Other Study ID Numbers: CDR0000067322
P30CA016087 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 6, 2011
Last Verified: April 2011
Keywords provided by NYU Langone Health:
stage I gastric cancer
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic