Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020345
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2007-03-02
Brief Title:
Combination Chemotherapy and Radiation Therapy Plus Surgery in Treating Patients With Advanced Cancer of the Pancreas
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Study of Neoadjuvant Intraperitoneal Gemcitabine and Intravenous Gemcitabine With Radiotherapy Followed by Surgery and Adjuvant Intraperitoneal Gemcitabine Intravenous Gemcitabine and Fluorouracil in Patients With Advanced Adenocarcinoma of the Pancreas
Status:
COMPLETED
Status Verified Date:
2012-03
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 Giving the drugs in different ways such as directly into the abdomen and combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy plus surgery in treating patients who have advanced cancer of the pancreas
PURPOSE Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy plus surgery in treating patients who have advanced cancer of the pancreas
Detailed Description:
OBJECTIVES I Determine radiographic andor pathologic response time to disease progression and survival in patients with advanced adenocarcinoma of the pancreas treated with neoadjuvant intraperitoneal gemcitabine and intravenous gemcitabine with radiotherapy followed by surgery and adjuvant intraperitoneal gemcitabine intravenous gemcitabine and fluorouracil
II Determine the pharmacokinetics of intraperitoneal gemcitabine in these patients
III Correlate patterns of mRNA expression with response to this regimen and prognosis in these patients
PROTOCOL OUTLINE Patients receive gemcitabine intraperitoneally IP every 6 hours for 4 doses on day 1 Treatment repeats in 1 week for a total of 2 courses Beginning 1-3 weeks after completion of IP chemotherapy patients receive gemcitabine IV over 30-60 minutes on day 1 or 2 of each week and radiotherapy on days 1-5 of each week for 6 weeks Within 6 weeks after the completion of combination chemotherapy and radiotherapy patients with stable or responding disease undergo surgical resection Patients with completely resected extrapancreatic disease then receive 2 additional courses of IP gemcitabine beginning 1-3 weeks after surgery Beginning 3 weeks after the completion of IP chemotherapy patients receive gemcitabine IV once weekly for a total of 3 weeks and fluorouracil IV continuously for up to 6 months
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL
A total of 10-100 patients will be accrued for this study within 2 years
II Determine the pharmacokinetics of intraperitoneal gemcitabine in these patients
III Correlate patterns of mRNA expression with response to this regimen and prognosis in these patients
PROTOCOL OUTLINE Patients receive gemcitabine intraperitoneally IP every 6 hours for 4 doses on day 1 Treatment repeats in 1 week for a total of 2 courses Beginning 1-3 weeks after completion of IP chemotherapy patients receive gemcitabine IV over 30-60 minutes on day 1 or 2 of each week and radiotherapy on days 1-5 of each week for 6 weeks Within 6 weeks after the completion of combination chemotherapy and radiotherapy patients with stable or responding disease undergo surgical resection Patients with completely resected extrapancreatic disease then receive 2 additional courses of IP gemcitabine beginning 1-3 weeks after surgery Beginning 3 weeks after the completion of IP chemotherapy patients receive gemcitabine IV once weekly for a total of 3 weeks and fluorouracil IV continuously for up to 6 months
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL
A total of 10-100 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CDR0000068298 | None | None | None |
| NCI-00-C-0218 | None | None | None |