Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06115499
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2023-10-30
Brief Title:
The PLATINUM Trial Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA12 or PALB2-Associated Metastatic Pancreatic Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase IIIII Second-Line NABPLAGEM vs Nab-PaclitaxelGemcitabine in BRCA12 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma PLATINUM
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 IIIII trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel gemcitabine plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body metastatic and a known genetic mutation in the BRCA1 BRCA2 or PALB2 gene
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate and compare overall response rate ORR in patients with BRCA12 or PALB2 mutant pancreas cancer whose disease has progressed on front-line fluorouracil irinotecan leucovorin and oxaliplatin FOLFIRINOX treated with nab-paclitaxel gemcitabine and cisplatin NABPLAGEM nab-paclitaxel gemcitabine and cisplatin arm 1 versus nab-paclitaxel and gemcitabine arm 2 Phase II II To evaluate and compare overall survival OS time in patients with BRCA12 or PALB2 mutant whose disease has progressed on front-line FOLFIRINOX treated with 1 NABPLAGEM nab-paclitaxel gemcitabine and cisplatin arm 1 versus nab-paclitaxel and gemcitabine arm 2 Phase III
SECONDARY OBJECTIVES
I To evaluate and compare progression-free survival PFS per Response Evaluation Criteria in Solid Tumors 11 RECIST 11 criteria between 2 treatment arms
II To evaluate and compare duration of response DoR between 2 treatment arms
III To evaluate and compare CA19-9 response defined as patients with a baseline CA19-9 2x upper limit of normal ULN who demonstrate a minimum 25 decrease in CA19-9 at any time point between 2 treatment arms
IV To evaluate and compare toxicity profile as assessed by treating clinicians between 2 treatment arms
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive nab-paclitaxel intravenously IV over 30-40 minutes gemcitabine IV over 30-40 minutes and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo magnetic resonance imaging MRI or computed tomography CT throughout the trial Patients may optionally undergo blood sample collection at baseline and on study
ARM II Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo MRI or CT throughout the trial Patients may optionally undergo blood sample collection at baseline and on study
After completion of study treatment patients are followed up within 30 days and then every 3 months for 2 years or until death whichever comes first
I To evaluate and compare overall response rate ORR in patients with BRCA12 or PALB2 mutant pancreas cancer whose disease has progressed on front-line fluorouracil irinotecan leucovorin and oxaliplatin FOLFIRINOX treated with nab-paclitaxel gemcitabine and cisplatin NABPLAGEM nab-paclitaxel gemcitabine and cisplatin arm 1 versus nab-paclitaxel and gemcitabine arm 2 Phase II II To evaluate and compare overall survival OS time in patients with BRCA12 or PALB2 mutant whose disease has progressed on front-line FOLFIRINOX treated with 1 NABPLAGEM nab-paclitaxel gemcitabine and cisplatin arm 1 versus nab-paclitaxel and gemcitabine arm 2 Phase III
SECONDARY OBJECTIVES
I To evaluate and compare progression-free survival PFS per Response Evaluation Criteria in Solid Tumors 11 RECIST 11 criteria between 2 treatment arms
II To evaluate and compare duration of response DoR between 2 treatment arms
III To evaluate and compare CA19-9 response defined as patients with a baseline CA19-9 2x upper limit of normal ULN who demonstrate a minimum 25 decrease in CA19-9 at any time point between 2 treatment arms
IV To evaluate and compare toxicity profile as assessed by treating clinicians between 2 treatment arms
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive nab-paclitaxel intravenously IV over 30-40 minutes gemcitabine IV over 30-40 minutes and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo magnetic resonance imaging MRI or computed tomography CT throughout the trial Patients may optionally undergo blood sample collection at baseline and on study
ARM II Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo MRI or CT throughout the trial Patients may optionally undergo blood sample collection at baseline and on study
After completion of study treatment patients are followed up within 30 days and then every 3 months for 2 years or until death whichever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2023-06547 | OTHER | NCI Clinical Trial Reporting Program | None |