Colorectal Cancer Clinical Trial
Official title:
Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies
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 giving them by intraperitoneal
infusion may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of intraperitoneal combination
chemotherapy in treating patients who have stage III ovarian epithelial cancer or
gastrointestinal cancer.
OBJECTIVES:
- Assess tolerance and complications from consolidation therapy with intraperitoneal
floxuridine and cisplatin and/or carboplatin in patients with stage III ovarian
epithelial cancer or gastrointestinal cancer with peritoneal involvement.
- Determine the sites of failure and estimate the time to failure following treatment
with this regimen in these patients.
OUTLINE: Patients are stratified according to type of residual disease at second look
laparotomy or laparoscopy (micro only vs no greater than 0.5 cm vs greater than 0.5 cm and
no greater than 1 cm), and by CA-125 level (elevated vs normal on day -7).
Patients receive intraperitoneal floxuridine on days 1-3 followed by intraperitoneal
cisplatin and/or carboplatin on day 3. Treatment continues every 3 weeks for 4-6 courses in
the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 and 6 weeks, then at 6, 12, 18, and 24 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 2 years.
;
Primary Purpose: Treatment
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