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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

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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 CenterNew York, New York  10016