Ignite Creation Date:
2024-05-05 @ 9:12 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00833859
Status:
TERMINATED
Last Update Posted:
2017-10-09
First Post:
2009-01-30
Brief Title:
Neoadjuvant Gemcitabine Docetaxel and Capecitabine in Combination With Stereotactic Radiosurgery
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
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 patients tumor followed by more chemotherapy can increase the chances that the patients pancreatic tumor can be removed completely
Detailed Description:
Cycle 1 and 2
Days 4 11 and 25 32 gemcitabine 750 mgm2 intravenous piggy back IVPB over 30 min
Days 4 11 and 25 32 docetaxel 30 mgm2 IVPB over 1 hour
Days 1-14 and 22-35 capecitabine 750 mgm2 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 mgm2 IVPB over 30 min
Days 54 61 and 75 82 docetaxel 30 mgm2 IVPB over 1 hour
Days 51-64 capecitabine 750 mgm2 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 mgm2 intravenous piggy back IVPB over 30 min
Days 4 11 and 25 32 docetaxel 30 mgm2 IVPB over 1 hour
Days 1-14 and 22-35 capecitabine 750 mgm2 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 mgm2 IVPB over 30 min
Days 54 61 and 75 82 docetaxel 30 mgm2 IVPB over 1 hour
Days 51-64 capecitabine 750 mgm2 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:
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 |
|---|---|---|---|
| IST 14091 | OTHER | Sanofi-Aventis US Inc | None |