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
18 Years
N/A
Both
Gastric Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Elliot Newman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000067322
NCT ID:
NCT00004103
Start Date:
July 1998
Completion Date:
June 2009
Related Keywords:
- Gastric Cancer
- stage I gastric cancer
- stage II gastric cancer
- stage III gastric cancer
- stage IV gastric cancer
- Stomach Neoplasms
Name | Location |
|---|---|
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
