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

Launched by MAYO CLINIC · Oct 27, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with metastatic pancreatic cancer, which means the cancer has spread beyond the pancreas to other parts of the body. The study is testing a combination of three chemotherapy drugs—Nab-Paclitaxel, Cisplatin, and Gemcitabine—along with a therapy called Tumor Treatment Fields (TTF). TTF uses electrical fields to help disrupt cancer cell growth. This trial is currently looking for participants who are adults aged 18 and older with a confirmed diagnosis of pancreatic adenocarcinoma that has spread to the liver, and who have not yet received treatment for their advanced cancer.

Eligible participants can expect to receive this combination treatment at a single location and will closely monitor their health throughout the study. It's important for potential participants to meet certain health criteria, including having specific blood counts and liver function levels, as well as not having brain metastasis or prior treatment for their metastatic cancer. The trial aims to assess the safety and effectiveness of this novel treatment approach, and participants will be closely supported by the medical team during the process. If you or someone you know may be interested in this trial, it could be a chance to access new therapy options for managing pancreatic cancer.

Gender

ALL

Eligibility criteria

• 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.