Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005049
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
2000-04-06
Brief Title:
Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Pilot Study of Intraperitoneal IP Therapy With Cisplatin or Carboplatin and Floxuridine FUdR as Consolidation for Ovarian and Gastrointestinal Malignancies
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 05 cm vs greater than 05 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 andor 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
Assess tolerance and complications from consolidation therapy with intraperitoneal floxuridine and cisplatin andor 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 05 cm vs greater than 05 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 andor 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1717 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |
| P30CA016087 | NIH | None | None |
| NYU-9645 | None | None | None |