Trials / Completed
CompletedNCT00005049
Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Colorectal Cancer
- Gastric Cancer
- Gastrointestinal Carcinoid Tumor
- Gastrointestinal Stromal Tumor
- Ovarian Cancer
- Peritoneal Cavity Cancer
- Small Intestine Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carboplatin | |
| DRUG | cisplatin | |
| DRUG | floxuridine |
Timeline
- Start date
- 1997-05-01
- Primary completion
- 2006-11-01
- First posted
- 2003-01-27
- Last updated
- 2011-04-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00005049. Inclusion in this directory is not an endorsement.