Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    30
  • sponsor
    Benaroya Research Institute
Updated on 15 February 2022
platelet count
paclitaxel
cancer
fluorouracil
neutrophil count
gemcitabine
leucovorin
irinotecan
blood transfusion
biliary obstruction
resectable pancreatic cancer

Summary

Using alternative neoadjuvant gemcitabine-nab-paclitaxel and nal-IRI with 5-Fluorouracil (5FU) and folinic acid (Leucovorin) regimens of localized cancer, we hope to ensure exposure of the cancer to a broader array of potentially active agents. Also, potentially improves patient tolerance and minimizes significant drug toxicity that could impair delivery of all treatment elements. Furthermore, it may enable prediction of superior to inferior treatment outcomes at an earlier point in the disease progress.

Description

This research study is a Phase Ib clinical trial. It will assess the Safety, tolerability, and feasibility of gemcitabine-nab paclitaxel alternating with nal-IRI/5FU/leucovorin (NAPOLI) in de novo resectable and borderline resectable pancreatic cancer.

Subjects must have a newly diagnosed resectable or borderline resectable pancreatic ductal cancer and meet all inclusion/exclusion criteria.

Treatment consists of 4 week treatment cycles. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15 with NAPOLI will be administered on days 1 and 15.

Details
Condition Pancreatic Adenocarcinoma
Treatment Gemcitabine, 5-FU, Leucovorin, Onivyde, nab paclitaxel
Clinical Study IdentifierNCT03703063
SponsorBenaroya Research Institute
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathologically proven resectable or borderline resectable pancreatic cancer per current NCCN criteria (<http://www.nccn.org/professionals/physician_gls/f_guidelines.asp>)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0/1
Adequate bone marrow reserves as evidenced by
absolute neutrophil count (ANC) 1,500 cells/l without the use of hematopoietic growth factors; and
Platelet count 100,000 cells/l; and
Hemoglobin 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL)
Adequate hepatic function as evidenced by
Serum total bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction); and
aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
5 x upper limit of normal (ULN) (5 x ULN is acceptable if liver metastases are present)
Adequate renal function as evidenced by a serum creatinine 1.5 x ULN
At least 18 years of age
Women of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must: Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption for 28 days prior to starting study medications (including dose interruptions) and for 3 months after last dose of study medication and Have a negative pregnancy test result at screening and agree to ongoing pregnancy testing at the Investigator's discretion during the course of the study. This applies even if the subject practices true abstinence from heterosexual contact
Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with study medications and for 3 months following the last dose of study medication, even if he has undergone a successful vasectomy

Exclusion Criteria

Prior therapy for pancreatic cancer (e.g., attempted surgery, chemotherapy, radiation therapy)
Any contraindication to curative surgery
History of any second malignancy in the last 5 years except in-situ cancer or basal or squamous cell skin cancer. Subjects with history of other malignancies are eligible if they have been continuously disease free for at least 5 years
Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before study participation
New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
Active infection or an unexplained fever >38.5C during screening visit or on the first scheduled day of dosing in each cycle which, in the Investigator's opinion, might compromise the subject's participation in the trial or affect the study outcome. Subjects with tumor fever may be enrolled at the discretion of the Investigator
Known hypersensitivity to any of the components of nal-IRI, other liposomal products, fluoropyrimidines or leucovorin
Neuropathy > grade 1
Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study
Any other medical or social condition deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and/or participate in the study in any way, or interfere with the interpretation of the results
Inability or unwillingness to provide written informed consent
Patients who are not appropriate candidates for participation in this clinical study for any other reason as determined by the investigator
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