Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry NYU-9822 P-UPJOHN-647597196, NCI-G99-1594, NCT00004103

Objectives

1. 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.
2. Determine the rate of potentially curative surgery in patients receiving this regimen.
3. Determine the toxicity and tolerance of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Newman E, Potmesil M, Ryan T, et al.: Neoadjuvant chemotherapy, surgery, and adjuvant intraperitoneal chemotherapy in patients with locally advanced gastric or gastroesophageal junction carcinoma: a phase II study. Semin Oncol 32 (6 Suppl 9): S97-100, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NYU Cancer Institute at New York University Medical Center

Howard Hochster, MD, Protocol chair		Ph: 212-731-5100 Email: howard.hochster@med.nyu.edu

Registry Information
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
Trial Start Date		1998-07-23
Registered in ClinicalTrials.gov		NCT00004103
Date Submitted to PDQ		1999-09-10
Information Last Verified		2005-12-07
NCI Grant/Contract Number		P30-CA16087

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