Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003018
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
1999-11-01
Brief Title:
S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Infusional 5-Fluorouracil 5-FU Calcium Leucovorin LV Mitomycin-C Mito-C and Dipyridamole D in Patients With Locally Advanced Unresected Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 may kill more tumor cells Chemotherapy following surgery may be an effective treatment for pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed
Detailed Description:
OBJECTIVES I Assess the one year overall survival rate of patients with advanced unresectable pancreatic cancer treated with fluorouracil leucovorin mitomycin and dipyridamole II Assess the response rate in this group of patients III Evaluate the frequency and severity of the toxic effects associated with this therapy IV Assess the rate of resectability in patients who respond to therapy
OUTLINE All patients undergo surgical placement of an indwelling central venous line Patients receive fluorouracil IV by continuous infusion on days 1-28 leucovorin calcium IV on days 1 8 15 and 22 oral dipyridamole on days 1-28 and mitomycin IV every 6 weeks starting on day 1 Treatment repeats every 6 weeks for 4 courses Patients with a partial or complete response are reevaluated for possible surgical resection Resected patients resume chemotherapy 4-8 weeks after surgery for an additional 16 weeks Patients are followed every 6 months for 2 years then annually until death
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
OUTLINE All patients undergo surgical placement of an indwelling central venous line Patients receive fluorouracil IV by continuous infusion on days 1-28 leucovorin calcium IV on days 1 8 15 and 22 oral dipyridamole on days 1-28 and mitomycin IV every 6 weeks starting on day 1 Treatment repeats every 6 weeks for 4 courses Patients with a partial or complete response are reevaluated for possible surgical resection Resected patients resume chemotherapy 4-8 weeks after surgery for an additional 16 weeks Patients are followed every 6 months for 2 years then annually until death
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study
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 |
|---|---|---|---|
| S9700 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |