Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC
Status and phase
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Study type
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Identifiers
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Histologically or cytologically confirmed pancreatic adenocarcinoma or adenosquamous carcinoma with liver metastasis. Liver metastasis can be confirmed histologically / cytologically or radiologically
- 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 and acinar-adenocarcinoma histologies 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 (magnetic resonance imaging [MRI]/computed tomography [CT] scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult
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Patients with no prior lines of therapy for the treatment of stage IV metastatic disease
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Patients could have had prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy
- Patients who received gemcitabine-based adjuvant chemotherapy can enroll if they progress > 6 months after completion of the therapy
- Patients who progress while on adjuvant fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX) can enroll immediately
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Male and female patients at least 18 years of age
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Absolute neutrophil count (ANC) > 1500 cells/mm^3
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Platelet count > 100,000 cells/mm^3
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Hemoglobin >= 8 g/dL
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Total bilirubin < 1.5 X upper limit of normal (ULN)
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Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 X ULN
- For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 6.0 X ULN and total bilirubin < 3 x ULN
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Serum creatinine within normal limits (WNL) or creatinine clearance > 50 mL/min
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QT intervals: corrected QT (QTc) =< 470 msec for men and =< 490 msec for women (as measured by Hodges' Equation)
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Estimated life expectancy of at least 3 months
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Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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Ability to operate the Novo TTF-100L (P) / Novo TTF-200T system
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Patients must have measurable disease on scans per RECIST 1.1
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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
- 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
- Patients who are pregnant or breastfeeding
- Patients who lack the capacity to consent for themselves
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Clinical Trials Referral Office
Data sourced from clinicaltrials.gov
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