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Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004103
First Posted: January 27, 2003
Last Update Posted: April 6, 2011
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
New York University School of Medicine
  Purpose

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 Intervention Phase
Gastric Cancer Drug: cisplatin Drug: floxuridine Drug: irinotecan hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Study Start Date: July 1998
Study Completion Date: June 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00004103


Locations
United States, New York
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Investigators
Study Chair: Elliot Newman, MD New York University School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004103     History of Changes
Other Study ID Numbers: CDR0000067322
P30CA016087 ( U.S. NIH Grant/Contract )
NYU-9822
P-UPJOHN-647597196
NCI-G99-1594
First Submitted: December 10, 1999
First Posted: January 27, 2003
Last Update Posted: April 6, 2011
Last Verified: April 2011

Keywords provided by New York University School of Medicine:
stage I gastric cancer
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Cisplatin
Floxuridine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites