Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00004103
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
1999-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
A Phase II Study of Systemic Therapy With CPT-11 (Camptosar HCl) and Cisplatin in Patients With Advanced Gastric Cancer to be Followed by Surgical Resection and Postoperative Intraperitoneal Chemotherapy
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 combining chemotherapy with surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.
PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.
Detailed Description:
OBJECTIVES:
* Determine the complete and partial response rates and time to treatment failure in patients with advanced gastric cancer treated with neoadjuvant irinotecan and cisplatin followed by surgery then intraperitoneal floxuridine and cisplatin.
* Determine the rate of potentially curative surgery in patients receiving this regimen.
* Determine the toxicity and tolerance of this regimen in these patients.
OUTLINE: Patients receive cisplatin IV and irinotecan IV once a week for 4 weeks. This course is repeated 2 weeks later.
Patients who achieve complete or partial remission or stable disease undergo resection 4 weeks after the last chemotherapy dose.
Patients with no residual macroscopic disease begin adjuvant intraperitoneal (IP) chemotherapy 1 week after surgery. Chemotherapy consists of floxuridine IP over 30 minutes on days 1-3 and days 22-24 and cisplatin IP on days 3 and 24.
PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 2 years.
* Determine the complete and partial response rates and time to treatment failure in patients with advanced gastric cancer treated with neoadjuvant irinotecan and cisplatin followed by surgery then intraperitoneal floxuridine and cisplatin.
* Determine the rate of potentially curative surgery in patients receiving this regimen.
* Determine the toxicity and tolerance of this regimen in these patients.
OUTLINE: Patients receive cisplatin IV and irinotecan IV once a week for 4 weeks. This course is repeated 2 weeks later.
Patients who achieve complete or partial remission or stable disease undergo resection 4 weeks after the last chemotherapy dose.
Patients with no residual macroscopic disease begin adjuvant intraperitoneal (IP) chemotherapy 1 week after surgery. Chemotherapy consists of floxuridine IP over 30 minutes on days 1-3 and days 22-24 and cisplatin IP on days 3 and 24.
PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-G99-1594 | None | None | View | |
| P30CA016087 | NIH | None | https://reporter.nih.gov/quic… | View |
| NYU-9822 | None | None | View | |
| P-UPJOHN-647597196 | None | None | View |