Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-05 @ 6:52 PM
Study NCT ID:
NCT00833859
Status:
TERMINATED
Last Update Posted:
2017-10-09
First Post:
2009-01-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
Official Title:
A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Abandoned - Lack of funding after only 2 patients enrolled
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 find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed completely.
Detailed Description:
* Cycle 1 and 2:
* Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m\^2 intravenous piggy back (IVPB) over 30 min
* Days 4, 11 and 25, 32 ....docetaxel 30 mg/m\^2 IVPB over 1 hour
* Days 1-14 and 22-35 ....capecitabine 750 mg/m\^2 oral twice daily
* Each cycle is 21 days long
* SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume
* Cycle 3 and 4:
* Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m\^2 IVPB over 30 min
* Days 54, 61 and 75, 82 ....docetaxel 30 mg/m\^2 IVPB over 1 hour
* Days 51-64 ....capecitabine 750 mg/m\^2 oral twice daily
* Each cycle is 21 days long
* Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or central pancreatectomy with or without vein resection and reconstruction as appropriate.
* Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m\^2 intravenous piggy back (IVPB) over 30 min
* Days 4, 11 and 25, 32 ....docetaxel 30 mg/m\^2 IVPB over 1 hour
* Days 1-14 and 22-35 ....capecitabine 750 mg/m\^2 oral twice daily
* Each cycle is 21 days long
* SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume
* Cycle 3 and 4:
* Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m\^2 IVPB over 30 min
* Days 54, 61 and 75, 82 ....docetaxel 30 mg/m\^2 IVPB over 1 hour
* Days 51-64 ....capecitabine 750 mg/m\^2 oral twice daily
* Each cycle is 21 days long
* Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or central pancreatectomy with or without vein resection and reconstruction as appropriate.
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 |
|---|---|---|---|---|
| IST 14091 | OTHER | Sanofi-Aventis US Inc. | View |