Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
|ClinicalTrials.gov Identifier: NCT00005049|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 6, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor Ovarian Cancer Peritoneal Cavity Cancer Small Intestine Cancer||Drug: carboplatin Drug: cisplatin Drug: floxuridine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Official Title:||Pilot Study of Intraperitoneal (IP) Therapy With Cisplatin or Carboplatin and Floxuridine (FUdR) as Consolidation for Ovarian and Gastrointestinal Malignancies|
|Study Start Date :||May 1997|
|Actual Primary Completion Date :||November 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005049
|United States, New York|
|NYU School of Medicine's Kaplan Comprehensive Cancer Center|
|New York, New York, United States, 10016|
|Study Chair:||Franco M. Muggia, MD||New York University School of Medicine|