Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer

Official Title: Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies

Study ID: NCT00005049

Conditions

Colorectal Cancer

Gastric Cancer

Gastrointestinal Carcinoid Tumor

Gastrointestinal Stromal Tumor

Ovarian Cancer

Peritoneal Cavity Cancer

Small Intestine Cancer

Interventions

carboplatin

cisplatin

floxuridine

Study Description

Brief Summary: 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.

Detailed Description: 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.