Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251355
Status:
COMPLETED
Last Update Posted:
2016-12-20
First Post:
2005-11-08
Brief Title:
Gemcitabine 5-Fluorouracil and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Study of Gemcitabine 5-Fluorouracil and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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:
The purpose of this study is to test a new treatment of pancreatic cancer that cannot be removed by surgery This treatment is a Phase I dose escalation research study which will combine one drug at increasing doses with a fixed dose of a second drug and radiation therapy The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil will remain the same for all patients
Detailed Description:
Ultimately we plan to find the maximum tolerated dose of the combination of gemcitabine 5-fluorouracil and radiation therapy We also hope to assess the number of people who respond to this therapy and to assess the feasibility of giving intraoperative radiation therapy following gemcitabine 5-fluorouracil and external beam radiation therapy
A surgical procedure either laparotomy or laparoscopy will be required to check the amount of disease before treatment is started
All patients will receive the same two chemotherapy drugs and radiation therapy Both gemcitabine and 5-fluorouracil will begin on the first week of radiation therapy 5-fluorouracil will be given continuously by intravenous infusion and will continue until the external beam radiation therapy is completed The gemcitabine will be given at different doses for each cohort of patients once per week for seven weeks Radiation therapy will be given daily for five days for seven weeks On those days when gemcitabine is given radiation therapy will be given approximately four hours after the gemcitabine dose
Four weeks after completing the radiation therapy and chemotherapy patients will undergo a scan to check the extent of disease Following the scan patients will be considered for a repeat surgical procedure to remove the tumor if possible If removal of the tumor is not possible patients will receive intraoperative radiation therapy
After completing the therapy patients will be seen at least every 3 months for one year A complete physical exam and CT scan will be done regularly
A surgical procedure either laparotomy or laparoscopy will be required to check the amount of disease before treatment is started
All patients will receive the same two chemotherapy drugs and radiation therapy Both gemcitabine and 5-fluorouracil will begin on the first week of radiation therapy 5-fluorouracil will be given continuously by intravenous infusion and will continue until the external beam radiation therapy is completed The gemcitabine will be given at different doses for each cohort of patients once per week for seven weeks Radiation therapy will be given daily for five days for seven weeks On those days when gemcitabine is given radiation therapy will be given approximately four hours after the gemcitabine dose
Four weeks after completing the radiation therapy and chemotherapy patients will undergo a scan to check the extent of disease Following the scan patients will be considered for a repeat surgical procedure to remove the tumor if possible If removal of the tumor is not possible patients will receive intraoperative radiation therapy
After completing the therapy patients will be seen at least every 3 months for one year A complete physical exam and CT scan will be done regularly
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