Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002955
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Pancreas
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Modulation of 5-Fluorouracil With Trimetrexate and Leucovorin in Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2014-05
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with advanced cancer of the pancreas
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with advanced cancer of the pancreas
Detailed Description:
OBJECTIVES I Evaluate tumor response to a trimetrexate fluorouracil and leucovorin regimen in patients with advanced pancreatic carcinoma II Evaluate the toxicities associated with this regimen in patients with metastatic carcinoma of the pancreas
OUTLINE The treatment plan consists of an IV infusion of trimetrexate followed 24 hours later by IV infusions of leucovorin and fluorouracil After another 24 hours oral leucovorin will be given every 6 hours for 7 doses A treatment cycle consists of the regimen repeated weekly for 6 weeks followed by 2 weeks of rest Treatment cycles will be repeated until disease progression or unacceptable toxicity
PROJECTED ACCRUAL If 3 or more complete or partial responses are observed in the first 22 patients an additional 11 patients may be accrued for a maximum of 33
OUTLINE The treatment plan consists of an IV infusion of trimetrexate followed 24 hours later by IV infusions of leucovorin and fluorouracil After another 24 hours oral leucovorin will be given every 6 hours for 7 doses A treatment cycle consists of the regimen repeated weekly for 6 weeks followed by 2 weeks of rest Treatment cycles will be repeated until disease progression or unacceptable toxicity
PROJECTED ACCRUAL If 3 or more complete or partial responses are observed in the first 22 patients an additional 11 patients may be accrued for a maximum of 33
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 |
|---|---|---|---|
| NCI-G97-1173 | None | None | None |
| LAC-USC-3P951 | None | None | None |