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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ twelve months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~twelve months
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).
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Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,554 Total Patients Enrolled
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,692 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,971 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer that has spread to my brain.I have received initial treatment for cancer that has spread.My cancer came back or spread after treatment, and a new biopsy wasn't done because scans showed clear signs.You are allergic or sensitive to the hydrogels used in the study.I am fully active or can carry out light work.My cancer is pancreatic with spread to the liver.Your doctor believes you will live for at least 3 more months.I am 18 years old or older.My cancer got worse while I was on FOLFIRINOX.You have any other health condition that, according to the doctor, would make you unable to participate in the study.I am not pregnant and will use birth control during and after the study.I had gemcitabine chemotherapy and my condition worsened more than 6 months after finishing it.I have cancer that has spread, but not to my brain.I am not taking any medication with a severe warning for heart rhythm problems that cannot be switched.I have a high risk of heart issues from medication due to past heart failure or heart attack.I have not received any treatments for my stage IV metastatic disease.My liver tests are within normal limits.My liver tests are within the required limits despite having liver cancer.My kidney function is normal or near normal.I have had chemotherapy or chemo-radiotherapy before surgery or as an initial treatment.My cancer is not squamous, small cell, or acinar but can be adeno-squamous.I have a pacemaker for my heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Modified GCN+TTF treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible to enroll in this trial at present?
"As per the information found on clinicaltrials.gov, this trial has openings and is actively searching for participants to join their ranks. This trial was first posted in April 1st 2022, with its last update appearing on April 4th 2021."
Answered by AI
How many participants are actively involved in this clinical trial?
"Affirmative. Clinicaltrials.gov displays that this investigation is recruiting right now, having been posted on the 1st of April 2022 and modified most recently on 4th of April 2022. It requires 40 participants to be recruited from two distinct medical locations."
Answered by AI
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