RECRUITING

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

Conditions

Pancreas Cancer Metastatic Pancreatic Cancer Pancreatic Adenocarcinoma Metastatic Adenocarcinoma GCN TTF Paclitaxel Cisplatin Gemcitabine Tumor Treatment Fields

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-01

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04605913

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 3. Male and female patients at least 18 years of age 4. Laboratory data as specified below: * Hepatic * Total bilirubin less than 1.5 X ULN; * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 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.	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.

Inclusion Criteria

Exclusion 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.
3. Male and female patients at least 18 years of age
4. Laboratory data as specified below:
* Hepatic
* Total bilirubin less than 1.5 X ULN;
* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 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.

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.

Contacts and Locations

Principal Investigator

Hani M. Babiker, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Jacksonville, Florida, 32224-9980

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Hani M. Babiker, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

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

Study Start Date2022-04-01

Study Completion Date2026-03

Study Record Updates

Study Start Date2022-04-01

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

GCN
TTF
Paclitaxel
Cisplatin
Gemcitabine
Tumor Treatment Fields

Additional Relevant MeSH Terms

Pancreas Cancer
Metastatic Pancreatic Cancer
Pancreatic Adenocarcinoma
Metastatic Adenocarcinoma