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The PLATINUM Trial: Optimizin...

The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-13

Study Completion Date

2029-12-09

Brief Summary

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This phase II/III 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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate and compare overall response rate (ORR) in patients with BRCA1/2 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 BRCA1/2 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 1.1 (RECIST 1.1) 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.

Conditions

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Pancreatic Acinar Cell Carcinoma Pancreatic Adenocarcinoma Pancreatic Adenosquamous Carcinoma Pancreatic Carcinoma Pancreatic Ductal Adenocarcinoma Pancreatic Squamous Cell Carcinoma Stage IV Pancreatic Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (nab-paclitaxel, gemcitabine, cisplatin)

Patients receive nab-paclitaxel 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 MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.

Group Type EXPERIMENTAL

Nab paclitaxel

Intervention Type DRUG

Given IV

Gemcitabine

Intervention Type DRUG

Given IV

Cisplatin

Intervention Type DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Arm II (nab-paclitaxel, gemcitabine)

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.

Group Type ACTIVE_COMPARATOR

Nab paclitaxel

Intervention Type DRUG

Given IV

Gemcitabine

Intervention Type DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Interventions

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Nab paclitaxel

Given IV

Intervention Type DRUG

Gemcitabine

Given IV

Intervention Type DRUG

Cisplatin

Given IV

Intervention Type DRUG

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Other Intervention Names

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ABI-007 Abraxane Albumin-bound Paclitaxel Protein-bound Paclitaxel MRI CAT Scan CT Scan

Eligibility Criteria

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Inclusion Criteria

* Metastatic pancreatic adenocarcinoma. Adenosquamous carcinoma, squamous carcinoma, acinar cell carcinoma, and carcinoma not otherwise specified are also acceptable
* BRCA1/2 or PALB2 mutation (somatic or germline) identified on any Clinical Laboratory Improvement Amendments (CLIA)-certified gene panel. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org. (Submission of mutation report will be required)
* Measurable disease
* Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment
* Clinical or radiographic progression on first-line FOLFIRINOX (or nanoliposomal irinotecan, fluorouracil, leucovorin, and oxaliplatin \[NALIRIFOX\]) for metastatic disease

* Patients whose front-line chemotherapy was required to be simplified due to toxicity associated with any of the constituent components of FOLFIRINOX/NALIRIFOX (e.g. simplified to leucovorin calcium, fluorouracil, and oxaliplatin \[FOLFOX\], leucovorin calcium, fluorouracil, and irinotecan \[FOLFIRI\], fluorouracil \[5-FU\] \[including capecitabine\]) will be eligible
* Patients with progressive disease while on maintenance PARP inhibitor treatment after FOLFIRINOX (or NALIRIFOX), irrespective of how long ago they received FOLFIRINOX/NALIRIFOX, will also be eligible
* Patients who develop metastatic disease during or within 6 months after completing FOLFIRINOX/NALIRIFOX in either the locally advanced or adjuvant/neoadjuvant settings will be eligible
* Patients may not have received prior cisplatin for their pancreatic cancer in any setting

\* Note: Patients may have previously received gemcitabine +/- nab-paclitaxel for resectable (neoadjuvant/adjuvant) or locally advanced disease if (1) treatment was completed \> 1 year ago and (2) in the opinion of the treating provider, re-treatment with gemcitabine/nab-paclitaxel is appropriate
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky performance status \>= 60)
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 8.0 g/dL
* Creatinine =\< 1.8 x institutional upper limit of normal (ULN) or calculated creatinine clearance (Calc. CrCl) \> 40 mL/min
* Total bilirubin =\< 2.0 x institutional ULN

\* Any elevated bilirubin should be asymptomatic at enrollment (except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin =\< 3 x ULN or direct bilirubin =\< 1.5 x ULN)
* Aspartate transaminase (AST)/alanine transaminase (ALT) =\< 3 x institutional ULN

\* AST/ALT of =\< 5 x ULN if liver metastases are present
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

\* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
* Patients with \> grade 2 peripheral sensory neuropathy are not eligible
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 8-weeks.

\* Patients with known, new or progressive brain metastases (active brain metastases) or leptomeningeal disease are ineligible
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load anytime within 6 months prior to registration are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

\* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Concomitant chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Exclusion Criteria

* N/A

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Site Status

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Site Status

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Site Status

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Site Status

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Site Status

Anchorage Oncology Centre

Anchorage, Alaska, United States

Site Status

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Site Status

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Site Status

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Site Status

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Site Status

Mercy San Juan Medical Center

Carmichael, California, United States

Site Status

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Site Status

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

UCI Health Laguna Hills

Laguna Hills, California, United States

Site Status

Mercy Cancer Center

Merced, California, United States

Site Status

Providence Queen of The Valley

Napa, California, United States

Site Status

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Site Status

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Site Status

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Site Status

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Site Status

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Site Status

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Site Status

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

Site Status

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Site Status

Saint Joseph's Medical Center

Stockton, California, United States

Site Status

Woodland Memorial Hospital

Woodland, California, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Site Status

CommonSpirit Cancer Center Mercy

Durango, Colorado, United States

Site Status

Mercy Medical Center

Durango, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

Saint Anthony North Hospital

Westminster, Colorado, United States

Site Status

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status