Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024271
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2001-09-13
Brief Title:
Surgery Chemotherapy and Radiation Therapy in Treating Patients With Peritoneal Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial Of Combined Resection Intraperitoneal Chemotherapy And Whole Abdominal Radiation For Treatment Of Peritoneal Mesothelioma
Status:
UNKNOWN
Status Verified Date:
2004-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Giving the drugs directly into the tumor after surgery and combining them with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining surgery chemotherapy and radiation therapy in treating patients who have peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of combining surgery chemotherapy and radiation therapy in treating patients who have peritoneal cancer
Detailed Description:
OBJECTIVES
Determine the response rate duration of response and duration of survival of patients with peritoneal mesothelioma treated with surgery intraperitoneal chemotherapy and whole abdominal radiotherapy
Determine the toxicity of this regimen in these patients
OUTLINE Patients undergo initial surgery including total omentectomy and excision of gross disease Approximately 3-4 weeks after surgery patients receive intraperitoneal IP chemotherapy consisting of doxorubicin IP over 2 hours once weekly on weeks 1 4 7 and 10 and cisplatin IP and gemcitabine IP once weekly on weeks 2 5 8 and 11 Patients also receive interferon gamma IP once weekly on weeks 13-16
At approximately week 18-20 patients undergo second-look surgery Patients with no gross disease receive hyperthermia mitomycin IP and cisplatin IP over 90 minutes
Approximately 2-4 weeks after second-look surgery patients undergo radiotherapy 5 days a week for 5-7 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
Determine the response rate duration of response and duration of survival of patients with peritoneal mesothelioma treated with surgery intraperitoneal chemotherapy and whole abdominal radiotherapy
Determine the toxicity of this regimen in these patients
OUTLINE Patients undergo initial surgery including total omentectomy and excision of gross disease Approximately 3-4 weeks after surgery patients receive intraperitoneal IP chemotherapy consisting of doxorubicin IP over 2 hours once weekly on weeks 1 4 7 and 10 and cisplatin IP and gemcitabine IP once weekly on weeks 2 5 8 and 11 Patients also receive interferon gamma IP once weekly on weeks 13-16
At approximately week 18-20 patients undergo second-look surgery Patients with no gross disease receive hyperthermia mitomycin IP and cisplatin IP over 90 minutes
Approximately 2-4 weeks after second-look surgery patients undergo radiotherapy 5 days a week for 5-7 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study
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-G01-2015 | None | None | None |
| CPMC-IRB-13799 | None | None | None |