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RecruitingPhase 1Phase 2NCT04605913

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

A Phase I/Ib Pilot Trial, Single Arm, Open Label, of Protein-Bound Paclitaxel, Cisplatin, and Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) in Patient With Metastatic Pancreatic Adenocarcinoma

Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Metastatic Pancreatic CancerPancreas CancerPancreatic AdenocarcinomaMetastatic Adenocarcinoma

Summary

This is a Phase I/Ib trial, single-center, non-randomized, open-label study of Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) and G+TTF maintenance therapy in patients with metastatic pancreatic cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a four-part treatment combining nab-paclitaxel, cisplatin, and gemcitabine (three chemotherapy drugs) with Tumor Treating Fields (TTFields) — a wearable device that delivers low-intensity electric fields to disrupt cancer cell division — for people with metastatic pancreatic cancer that has spread to the liver. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic pancreatic adenocarcinoma with liver metastases - You have not received prior treatment for metastatic (Stage IV) disease - Your overall health/functional status is good (ECOG 0–1) - Your blood counts, kidney, and liver function meet required levels - You are able to operate the TTFields wearable device **You may NOT be eligible if...** - You have received prior treatment for metastatic disease - You have brain metastases - You have a cardiac pacemaker or abdominal implanted device - You have significant heart problems (congestive heart failure or prior heart attack) - You are pregnant or breastfeeding - You have an allergy to the conductive gel used with the TTFields device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTModified GCN+TTF treatment

The regimen will consist of gemcitabine (G) administered at a dose of 800 mg/m2, cisplatin (C) 30 mg/m2, and protein-bound paclitaxel (N) 150 mg/m2 administered on cycle 1 day 1 and every 2 weeks thereafter and TTF will be administered daily (150kHz 18 hours/day) starting with Cycle 1 Day 1 (dose level 1). One cycle consists of 28 days including 2 chemotherapy treatments (same regimen studied in the PAXG trial: Reni BJC 2016 without capecitabine). After completing 6 cycles, patients will then transition to a maintenance phase of G administered at a dose of 1000 mg/m2 every 2 weeks and daily TTF (150 KHZ 18 hours/day) until progression of disease (POD) per RECIST v1.1.

Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT04605913

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