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Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
This study is ongoing, but not recruiting participants.
Study NCT00004103   Information provided by National Cancer Institute (NCI)
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes

December 10, 1999
February 6, 2009
July 1998
 
 
 
Complete list of historical versions of study NCT00004103 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
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

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.

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.

Phase II
Interventional
Treatment
Gastric Cancer
  • Drug: cisplatin
  • Drug: floxuridine
  • Drug: irinotecan hydrochloride
  • Procedure: adjuvant therapy
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
 
Newman E, Potmesil M, Ryan T, Marcus S, Hiotis S, Yee H, Norwood B, Wendell M, Muggia F, Hochster H. Neoadjuvant chemotherapy, surgery, and adjuvant intraperitoneal chemotherapy in patients with locally advanced gastric or gastroesophageal junction carcinoma: a phase II study. Semin Oncol. 2005 Dec;32(6 Suppl 9):S97-100.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004103
 
CDR0000067322, NYU-9822, P-UPJOHN-647597196, NCI-G99-1594
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Howard S. Hochster, MD New York University School of Medicine
National Cancer Institute (NCI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP