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

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Pancreatic Acinar Cell Carcinoma, Pancreatic Adenocarcinoma, Pancreatic Adenosquamous Carcinoma, Pancreatic Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Squamous Cell Carcinoma, Stage IV Pancreatic Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT06115499

Run by

Alliance for Clinical Trials in Oncology

People needed

10

Starts

2024-08-13

Expected to finish

2029-12-09

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• N/A

Where it is running

• Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Anchorage Oncology Centre — Anchorage, Alaska, United States
• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• CTCA at Western Regional Medical Center — Goodyear, Arizona, United States
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mercy Cancer Center - Carmichael — Carmichael, California, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• Mercy Cancer Center - Elk Grove — Elk Grove, California, United States
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• UCI Health Laguna Hills — Laguna Hills, California, United States
• Mercy Cancer Center — Merced, California, United States
• Providence Queen of The Valley — Napa, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Mercy Cancer Center - Rocklin — Rocklin, California, United States
• Mercy Cancer Center - Sacramento — Sacramento, California, United States
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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