Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001569
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion CHPP With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Trial of Continuous Hyperthermic Peritoneal Perfusion CHPP With Cisplatin Plus Early Postoperative Intraperitoneal Paclitaxel and 5-FU for Peritoneal Carcinomatosis
Status:
COMPLETED
Status Verified Date:
2002-12
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:
Two days prior to planned surgery paclitaxel is infused IV over 24 hours
Patients will undergo cytoreductive surgery to debulk tumor Scope of procedure will vary with each patient including a spectrum of possible procedures such as splenectomy liver resection pancreatic resection or bowel resection
After cytoreductive surgery continuous hyperthermic peritoneal perfusion CHPP surgery with cisplatin will begin by placing an influx and efflux catheters via abdominal wall Perfusion rate of cisplatin is 15 Lmin and the duration is 90 min
Postoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery
Dose escalation will proceed after patients at a given dose level receive 3 courses In order to properly evaluate hematoxicity a minimum of 3 weeks will be required before dose escalation MTD is either the dose level immediately below the level at which 2 of 6 patients in a cohort experience nonhematologic dose limiting toxicity DLT or when 4 of 6 patients experience hematologic DLT
Two to 4 months after surgery laparotomy will be conducted to determine response to treatment If tumor size is decreased patients will undergo a second treatment course identical to the same techniques and chemotherapy agents
Patients will undergo cytoreductive surgery to debulk tumor Scope of procedure will vary with each patient including a spectrum of possible procedures such as splenectomy liver resection pancreatic resection or bowel resection
After cytoreductive surgery continuous hyperthermic peritoneal perfusion CHPP surgery with cisplatin will begin by placing an influx and efflux catheters via abdominal wall Perfusion rate of cisplatin is 15 Lmin and the duration is 90 min
Postoperative intraperitoneal chemotherapy will begin 24 hours after CHPP surgery
Dose escalation will proceed after patients at a given dose level receive 3 courses In order to properly evaluate hematoxicity a minimum of 3 weeks will be required before dose escalation MTD is either the dose level immediately below the level at which 2 of 6 patients in a cohort experience nonhematologic dose limiting toxicity DLT or when 4 of 6 patients experience hematologic DLT
Two to 4 months after surgery laparotomy will be conducted to determine response to treatment If tumor size is decreased patients will undergo a second treatment course identical to the same techniques and chemotherapy agents
Detailed Description:
Peritoneal carcinomatosis is considered a terminal stage of tumor progression Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of this disease This study will define the maximum tolerated dose of paclitaxel and 5-fluorouracil 5-FU given as an early post-operative intraperitoneal IP dwell therapy after cytoreductive surgery and continuous hyperthermic peritoneal perfusion with cisplatin CHPP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-C-0072 | None | None | None |