- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04605913
Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Cody V. Mejia, CCRP
- Phone Number: 904-953-8789
- Email: Mejia.cody@mayo.edu
Study Locations
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Florida
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Jacksonville, Florida, United States, 32224-9980
- Recruiting
- Mayo Clinic
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Principal Investigator:
- Hani M. Babiker, M.D.
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Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.
- Subjects with additional sites of metastasis, except known brain metastasis, are eligible.
- Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous histology can be enrolled.
- 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.
Patients with no prior lines of therapy for the treatment of stage IV metastatic disease.
- 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.
- Male and female patients at least 18 years of age
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.
- 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).
- Estimated life expectancy of at least 3 months
- ECOG Performance Status 0-1.
- Ability to operate the Novo TTF-100L (P) system.
- Patients must have measurable disease on scans per RECIST 1.1.
- 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.
- Patients with known brain metastasis.
- Cardiac conduction abnormalities such as 2nd and 3rd heart-block requiring a pacemaker.
- Patient with cardiac or abdominal pacemakers or stimulators.
- Significant risk of cardiac drug toxicity due to congestive heart failure or history of myocardial infarction.
- Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible.
- Concomitant use of drugs that have black box warning of Torsades de Pointes will also be prohibited if cannot be replaced by another drug.
- Known sensitivity to conductive hydrogels.
10. Patients who are pregnant or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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 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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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).
One cycle consists of 28 days including 2 chemotherapy treatments (same regimen studied in the PAXG trial: Reni BJC 2016 without capecitabine).
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine safety of (m)-GCN+TTF
Time Frame: 28 days
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To determine the safety of modified (m)-GCN+TTF in patients with recurrent and/or metastatic pancreatic cancer (met-PC) by measuring grade 4 treatment related adverse events (TRAE).
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival
Time Frame: Six months
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Six months
|
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Overall Response Rate
Time Frame: Six months
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Objective responses in tumor size will be evaluated using the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).
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Six months
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Overall Survival
Time Frame: Twelve months
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Twelve months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hani M. Babiker, M.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MC210405
- NCI-2022-01522 (Other Grant/Funding Number: NCI)
- 21-011320 (Other Identifier: Mayo Clinic Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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