Ignite Creation Date:
2024-05-05 @ 11:54 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01442974
Status:
COMPLETED
Last Update Posted:
2013-03-13
First Post:
2011-06-13
Brief Title:
Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
Sponsor:
Grupo Hospital de Madrid
Organization:
Grupo Hospital de Madrid
Study Overview
Official Title:
Assessment Of Stromal Response To Nab-Paclitaxel In Combination With Gemcitabine In Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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:
Targeting tumor stroma is emerging as a strategic approach for pancreatic cancer treatment Actually one of the most interesting characteristics of pancreatic cancer is the dense fibrotic stroma surrounding tumor cells Moreover pancreatic cancer stroma seems to express a specific protein profile different from tumor cells For example secreted protein rich in cysteine SPARC is overexpressed in pancreatic tumor stroma fibroblast and downregulated in tumor cells This characteristic is associated with poor clinical outcome
Nab-paclitaxel an albumin bound nano formulation of paclitaxel that targets SPARC decreases tumor stroma density Such effect improves drug delivery and enhances both nab-paclitaxel and gemcitabine antitumor activity in nude mouse models
Based on this pre-clinical data the investigators designed a clinical trial of nab-paclitaxel in combination with gemcitabine as neo-adjuvant treatment for pancreatic cancer patients Fifteen SPARC positive patients will be enrolled in the study and treated with abraxane in combination with gemcitabine
This is a pilot study which primary end point is evaluating the effect of Abraxane in combination with gemcitabine on tumor stroma and the secondary end-point is correlating these changing with treatment activity
Nab-paclitaxel an albumin bound nano formulation of paclitaxel that targets SPARC decreases tumor stroma density Such effect improves drug delivery and enhances both nab-paclitaxel and gemcitabine antitumor activity in nude mouse models
Based on this pre-clinical data the investigators designed a clinical trial of nab-paclitaxel in combination with gemcitabine as neo-adjuvant treatment for pancreatic cancer patients Fifteen SPARC positive patients will be enrolled in the study and treated with abraxane in combination with gemcitabine
This is a pilot study which primary end point is evaluating the effect of Abraxane in combination with gemcitabine on tumor stroma and the secondary end-point is correlating these changing with treatment activity
Detailed Description:
Study Phase Pilot study to assess nab-paclitaxel in combination with gemcitabine effects on pancreatic cancer stroma and tumor metabolism
Study Objectives
A Primary end-points
1 Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma density
2 Evaluate the effect of nab-paclitaxel on tumor vessels formation
3 Evaluate the effect of nab-paclitaxel on tumor metabolism
B Secondary end-point
1 Evaluate combination activity in relation with changes in tumor stroma and tumor metabolic activity
The following studies will be performed prior and after treatment administration
18FDG-PETCT scan
Ultrasound Elastography
IHC
1 SPARC
2 Microvessel Density CD-31 VEGF-A
3 Stroma density SMA and Collagen I
Study population and Number of subject A total of 15 pancreatic cancer patients with resectableresectable borderline disease are expected to be enrolled
Study design and schedule This is a pilot study to evaluate the effect of nab-paclitaxel on tumor stroma in pancreatic cancer patients The study will be conducted in two parts
Part A Patients diagnosed with resectableresectable pancreatic cancer will be screened for SPARC expression Fifteen SPARC positive patients will be enrolled in the study and treated with nab-paclitaxel in combination with gemcitabine Patients will be treated as follow
nab-paclitaxel will be administered at 125 mgm2 as intravenous iv infusion over 30 minutes
followed by gemcitabine 1000 mgm2 iv infusion over 30 minutes
Treatment will be delivered weekly for 3 weeks on day 1 8 and 15 over 28 days cycle followed by a week of rest for two cycles of treatment
Part B At the end of treatment tumors will be surgically resected according to standard surgical procedure for the treatment of pancreatic cancer
Study Objectives
A Primary end-points
1 Evaluate the effect of nab-paclitaxel in combination with gemcitabine on tumor stroma density
2 Evaluate the effect of nab-paclitaxel on tumor vessels formation
3 Evaluate the effect of nab-paclitaxel on tumor metabolism
B Secondary end-point
1 Evaluate combination activity in relation with changes in tumor stroma and tumor metabolic activity
The following studies will be performed prior and after treatment administration
18FDG-PETCT scan
Ultrasound Elastography
IHC
1 SPARC
2 Microvessel Density CD-31 VEGF-A
3 Stroma density SMA and Collagen I
Study population and Number of subject A total of 15 pancreatic cancer patients with resectableresectable borderline disease are expected to be enrolled
Study design and schedule This is a pilot study to evaluate the effect of nab-paclitaxel on tumor stroma in pancreatic cancer patients The study will be conducted in two parts
Part A Patients diagnosed with resectableresectable pancreatic cancer will be screened for SPARC expression Fifteen SPARC positive patients will be enrolled in the study and treated with nab-paclitaxel in combination with gemcitabine Patients will be treated as follow
nab-paclitaxel will be administered at 125 mgm2 as intravenous iv infusion over 30 minutes
followed by gemcitabine 1000 mgm2 iv infusion over 30 minutes
Treatment will be delivered weekly for 3 weeks on day 1 8 and 15 over 28 days cycle followed by a week of rest for two cycles of treatment
Part B At the end of treatment tumors will be surgically resected according to standard surgical procedure for the treatment of pancreatic cancer
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