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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

Summary

This trial is testing a new combination of drugs and maintenance therapy for metastatic pancreatic cancer.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~twelve months
This trial's timeline: 3 weeks for screening, Varies for treatment, and twelve months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine safety of (m)-GCN+TTF
Secondary outcome measures
Overall Response Rate
Overall Survival
Progression-free Survival

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).

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.

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
518 Previous Clinical Trials
148,669 Total Patients Enrolled
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,684 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,366 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04605913 — Phase 1 & 2
Pancreatic Adenocarcinoma Research Study Groups: Modified GCN+TTF treatment
Pancreatic Adenocarcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04605913 — Phase 1 & 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04605913 — Phase 1 & 2
~8 spots leftby Mar 2025