Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423326
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-04-10
Brief Title:
Gemcitabine Cisplatin and Nab-Paclitaxel As Neoadjuvant Treatment for Patients with Resectable or Borderline Resectable Pancreatic Cancer
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Single-Arm Phase II Clinical Trial of Gemcitabine Cisplatin and Nab-Paclitaxel As Neoadjuvant Therapy for Pancreatic Ductal Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-08
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 II trial tests how well gemcitabine cisplatin and nab-paclitaxel given before surgery neoadjuvant works in treating patients with pancreatic cancer that can be removed by surgery resectable or that is borderline resectable The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy Neoadjuvant therapy has been shown to improve overall survival compared to patients receiving surgery first Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells Cisplatin is in a class of medications known as platinum-containing compounds It works by killing stopping or slowing the growth of tumor cells Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel Gemcitabine cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVE
I Determine the major pathological response rate feasibility and safety of biweekly gemcitabine cisplatin and nab-paclitaxel GCN in the neoadjuvant setting for patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
SECONDARY OBJECTIVE
I Determine if neoadjuvant GCN increases tumoral infiltration of lymphocytes with local and systemic phenotypic features that assist in the antitumor immune response
OUTLINE
Patients receive nab-paclitaxel intravenously IV over 30 minutes cisplatin IV over 60 minutes and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients with stable disease partial or complete response undergo surgical resection per standard of care Additionally patients undergo biopsy on study and undergo blood sample collection and computed tomography CT or magnetic resonance imaging MRI at pre-study and on study
After completion of study treatment patients are followed up every 3-4 months for up to 24 months
I Determine the major pathological response rate feasibility and safety of biweekly gemcitabine cisplatin and nab-paclitaxel GCN in the neoadjuvant setting for patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
SECONDARY OBJECTIVE
I Determine if neoadjuvant GCN increases tumoral infiltration of lymphocytes with local and systemic phenotypic features that assist in the antitumor immune response
OUTLINE
Patients receive nab-paclitaxel intravenously IV over 30 minutes cisplatin IV over 60 minutes and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients with stable disease partial or complete response undergo surgical resection per standard of care Additionally patients undergo biopsy on study and undergo blood sample collection and computed tomography CT or magnetic resonance imaging MRI at pre-study and on study
After completion of study treatment patients are followed up every 3-4 months for up to 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| STUDY00006976 | OTHER | Emory University HospitalWinship Cancer Institute | httpsreporternihgovquickSearchP30CA138292 |
| NCI-2024-02082 | REGISTRY | None | None |
| WINSHIP6093-23 | OTHER | None | None |
| P30CA138292 | NIH | None | None |