What is the mechanism of action of this treatment?

Common treatments for pancreatic cancer include chemotherapy agents such as gemcitabine, nab-paclitaxel, and cisplatin, as well as Tumor Treatment Fields (TTF). Gemcitabine works by inhibiting DNA synthesis, leading to cell death, while nab-paclitaxel disrupts microtubule function, preventing cell division. Cisplatin causes DNA crosslinking, which triggers apoptosis. TTF uses electric fields to disrupt cancer cell division. These mechanisms are crucial for pancreatic cancer patients as they target rapidly dividing cancer cells, potentially improving survival and quality of life.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as the combination of nab-paclitaxel, cisplatin, and gemcitabine, are associated with several side effects. Nab-paclitaxel and gemcitabine can cause fatigue, neuropathy, neutropenia, and diarrhea. Cisplatin is known for nephrotoxicity, ototoxicity, and nausea. Tumor Treatment Fields (TTF), which disrupt cell division using electric fields, may cause skin irritation at the application site. Patients undergoing these treatments should be monitored for these side effects and managed accordingly.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including gemcitabine and nab-paclitaxel (protein-bound paclitaxel). Gemcitabine was one of the first chemotherapeutic agents approved for pancreatic cancer, often used alone or in combination with other drugs. Nab-paclitaxel, in combination with gemcitabine, has shown improved response rates and survival in patients with metastatic pancreatic cancer. Cisplatin, although not specifically approved for pancreatic cancer, is sometimes used off-label in combination regimens. Tumor Treatment Fields (TTF) represent a novel, non-invasive treatment modality that disrupts cancer cell division using electric fields and is currently being studied in combination with these chemotherapeutic agents.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) Nab-paclitaxel plus gemcitabine, which has shown increased survival in advanced pancreatic cancer. 2) FOLFOX regimen for patients with high serum bilirubin levels. 3) Immunotherapy options such as anti-PD-1 or anti-PD-L1 therapy, particularly for patients with high tumor mutational burden. These alternatives have demonstrated efficacy in clinical trials and may offer new avenues for treatment.

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Alkylating agents

Combination Chemotherapy + TTF for Pancreatic Cancer

Phase 1 & 2

Recruiting

Led By Hani M. Babiker, M.D.

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status 0-1

Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis

Must not have

Patients with known brain metastasis

Previous front-line therapy for metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for advanced pancreatic cancer using a mix of three chemotherapy drugs and a special device that uses electric fields to target cancer cells. Patients continue with one drug and the electric field device. The goal is to find a more effective front-line therapy for patients whose cancer has spread. The use of electric fields to disrupt cancer cell division is a novel approach that has shown promise in other cancers, such as malignant pleural mesothelioma.

Who is the study for?

This trial is for adults with stage IV metastatic pancreatic cancer who haven't had treatment for advanced disease. They can join if they've had certain previous therapies, but not if they have brain metastasis or heart issues. Participants need functioning major organs and no severe cardiac risks, and women must not be pregnant.

What is being tested?

The study tests a combination of chemotherapy drugs (Protein-bound Paclitaxel, Cisplatin, Gemcitabine) with Tumor Treatment Fields (TTF), followed by maintenance therapy. It's an early-phase trial to see how safe this approach is and how well it works in patients.

What are the potential side effects?

Possible side effects include reactions to the chemo like nausea, fatigue, blood cell count changes; skin irritation from TTF; liver function changes; and potential heart rhythm problems due to QT interval prolongation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is pancreatic with spread to the liver.

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I have not received any treatments for my stage IV metastatic disease.

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My liver tests are within normal limits.

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My liver tests are within the required limits despite having liver cancer.

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My kidney function is normal or near normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer that has spread to my brain.

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I have received initial treatment for cancer that has spread.

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I have a high risk of heart issues from medication due to past heart failure or heart attack.

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I have a pacemaker for my heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine safety of (m)-GCN+TTF

Secondary study objectives

Overall Response Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Modified GCN+TTF treatmentExperimental Treatment1 Intervention

The trial will compose of 2 parts with a total of 40 subjects. 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). 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. If 6 patients tolerate the dose level of GCN+TTF through the 1st cycle without defined dose limiting toxicities (DLTs) or grade 4 treatment related adverse events (TRAE), the 2nd part of the study (phase Ib portion) will commence. An additional 34 patients will be enrolled in the expansion cohort (phase Ib).

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include chemotherapy agents such as gemcitabine, nab-paclitaxel, and cisplatin, as well as Tumor Treatment Fields (TTF). Gemcitabine works by inhibiting DNA synthesis, leading to cell death, while nab-paclitaxel disrupts microtubule function, preventing cell division. Cisplatin causes DNA crosslinking, which triggers apoptosis. TTF uses electric fields to disrupt cancer cell division. These mechanisms are crucial for pancreatic cancer patients as they target rapidly dividing cancer cells, potentially improving survival and quality of life.