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Clinical Trial Record

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

2022-04-01

2026-03-01

2026-03-01

40

Study Overview

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

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.

GCN is predicted to be the front-line therapy for biliary and pancreatic cancer in the future given excellent results of current early clinical trials (ORR ≥ 67% in pancreatic cancer). This will change standard of care for front-line therapy in patients with stage IV pancreatic cancer. In this cohort of patients' tolerability after 6 cycles of therapy will be a challenge. Investigators hypothesize that developing a maintenance strategy with TTF+G will be cutting edge approach and can potentially transform front-line standard of care therapy in patients with stage IV pancreatic cancer. If this pilot study proves fruitful then a larger study to confirm findings can be conducted.

  • Pancreas Cancer
  • Metastatic Pancreatic Cancer
  • Pancreatic Adenocarcinoma
  • Metastatic Adenocarcinoma
  • COMBINATION_PRODUCT: Modified GCN+TTF treatment
  • MC210405
  • NCI-2022-01522 (OTHER_GRANT Identifier) (OTHER_GRANT: CTRP (Clinical Trial Reporting Program))
  • 21-011320 (OTHER Identifier) (OTHER: Mayo Clinic Institutional Review Board)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-09-28  

N/A  

2025-03-19  

2020-10-27  

N/A  

2025-03-24  

2020-10-28  

N/A  

2025-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Modified GCN+TTF treatment

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 we

COMBINATION_PRODUCT: Modified 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 ho
Primary Outcome MeasuresMeasure DescriptionTime Frame
Safety of (m)-GCN+TTFAssessed by incidence of adverse events, as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.28 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Progression-free Survival (PFS)PFS is defined as the time from the date of registration to the earliest date of documented evidence of recurrent or progressive disease or the date of death due to any cause.Six months
Overall Response Rate (ORR)ORR will be assessed by the percentage of patients achieving complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), as evaluated using the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).Six months
Overall Survival (OS)OS is defined as the time from the date of registration to the date of death due to any cause, or the date of last contact (censored observations).Twelve months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Clinical Trials Referral Office

Phone Number: 855-776-0015

Email: mayocliniccancerstudies@mayo.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.
    1. Subjects with additional sites of metastasis, except known brain metastasis, are eligible. 2. Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous histology can be enrolled. 3. Patients who have recurrence or metastasis after surgery and adjuvant therapy do not need repeat biopsy for confirmation of recurrence if clinical suspicion is high per scans (MRI/CT scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult. 2. Patients with no prior lines of therapy for the treatment of stage IV metastatic disease.
    1. Patients could have had prior neoadjuvant or adjuvant chemotherapy or chemo-radiotherapy.
    i. Patients who received gemcitabine-based adjuvant chemotherapy can enroll if they progress greater than 6 months after completion of the therapy; ii. Patients who progress while on adjuvant FOLFIRINOX can enroll immediately. 3. Male and female patients at least 18 years of age 4. Laboratory data as specified below:
    Hematology:
    - ANC greater than 1500 cells/mm3,
    - platelet count greater than 100,000 cells/mm3, and
    - Hemoglobin greater than 8 g/dL.
  • Hepatic


  • Total bilirubin less than 1.5 X ULN;
  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 X ULN.

    • For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 6.0 X ULN and total bilirubin less than 3 x ULN.
  • Renal:


  • serum creatinine WNL or creatinine clearance greater than 50 mL/min. 5. QT intervals: QTc less than or equal to 470 msec for men and less than or equal to 490 msec for women. (As measured by Hodges' Equation: QTc = QT + 1.75(rate-60) where QTc = corrected QT interval and rate = ventricular rate/min). 6. Estimated life expectancy of at least 3 months 7. ECOG Performance Status 0-1. 8. Ability to operate the Novo TTF-100L (P) system. 9. Patients must have measurable disease on scans per RECIST 1.1. 10. Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment.

    • Exclusion Criteria:
    1. Previous front-line therapy for metastatic disease.
    1. Patients with known brain metastasis. 2. Cardiac conduction abnormalities such as 2nd and 3rd heart-block requiring a pacemaker. 3. Patient with cardiac or abdominal pacemakers or stimulators. 4. Significant risk of cardiac drug toxicity due to congestive heart failure or history of myocardial infarction. 5. Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible. 6. Concomitant use of drugs that have black box warning of Torsades de Pointes will also be prohibited if cannot be replaced by another drug. 7. Known sensitivity to conductive hydrogels.
    10. Patients who are pregnant or breastfeeding.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • NovoCure Ltd.
  • PRINCIPAL_INVESTIGATOR: Hani M. Babiker, MD, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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