Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-04-16 @ 6:31 AM
Study NCT ID:
NCT01893294
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2013-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemcitabine Hydrochloride in Treating Patients With Locally Advanced Pancreatic Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Phase I Trial of Intra-tumoral Gemcitabine Therapy for Locally Advanced Pancreatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-10
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:
This phase I trial studies the side effects and best dose of gemcitabine hydrochloride in treating patients with locally advanced pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerate dose (MTD) of intra-tumoral injection of gemcitabine (gemcitabine hydrochloride) when administered as a one time initial induction therapy in conjunction (=\< 33 hours) prior to conventional multimodality treatment for locally advanced pancreatic cancer (LAPC).
SECONDARY OBJECTIVES:
I. To evaluate the initial and delayed toxicity associated with this treatment regimen.
OUTLINE: This is a dose-escalation study.
Patients receive gemcitabine hydrochloride intratumorally (IT) on day 1. Within 33 hours, patients receive standard chemotherapy comprising fluorouracil intravenously (IV) on days 1, 8, 15, 22, 29, and 36 and undergo standard radiation therapy 5 days a week for 6 weeks.
After completion of study treatment, patients are followed up for 5 years.
I. To determine the maximum tolerate dose (MTD) of intra-tumoral injection of gemcitabine (gemcitabine hydrochloride) when administered as a one time initial induction therapy in conjunction (=\< 33 hours) prior to conventional multimodality treatment for locally advanced pancreatic cancer (LAPC).
SECONDARY OBJECTIVES:
I. To evaluate the initial and delayed toxicity associated with this treatment regimen.
OUTLINE: This is a dose-escalation study.
Patients receive gemcitabine hydrochloride intratumorally (IT) on day 1. Within 33 hours, patients receive standard chemotherapy comprising fluorouracil intravenously (IV) on days 1, 8, 15, 22, 29, and 36 and undergo standard radiation therapy 5 days a week for 6 weeks.
After completion of study treatment, patients are followed up for 5 years.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-00798 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| MC1241 | OTHER | Mayo Clinic | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |