Gemcitabine & Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology

  • STATUS
    Recruiting
  • End date
    May 1, 2023
  • participants needed
    21
  • sponsor
    Benaroya Research Institute
Updated on 15 February 2022
platelet count
paclitaxel
cancer
measurable disease
gemcitabine
biliary stents
pdac
ductal adenocarcinoma
pancreatic ductal adenocarcinoma

Summary

Using gemcitabine and nab-paclitaxel, the investigators hope to establish the differential ability of local and cytologically positive disease to respond to this regimen, and in particular, the frequency of cytologic conversion from positive to negative in such patients. The investigators also can begin to assess the value of maximum local therapy, including surgery, in patients who cytologically convert from positive to negative.

Description

This research study is a Phase Ib clinical trial. It will assess the frequency of cytological conversion in patients with pancreatic adenocarcinoma and positive peritoneal cytology as a sole metastatic site following gemcitabine nab-paclitaxel.

Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer with positive peritoneal cytology as a sole metastatic site 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.

Details
Condition Pancreatic Adenocarcinoma
Treatment Gemcitabine, Nab-paclitaxel
Clinical Study IdentifierNCT03703089
SponsorBenaroya Research Institute
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male, or a non-pregnant and non-lactating female
Age 18 years
Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
Radiographic and pathologic staging (including staging laparoscopy with peritoneal wash) consistent with pancreatic cancer, resectable, borderline resectable, or locally advanced or unresectable as defined by NCCN guidelines (<http://www.nccn.org/professionals/physician_gls/f_guidelines.asp>)
Laparoscopic confirmation that the PDAC is localized except for positive peritoneal cytology. Biliary stents are permitted
Elevated CA19-9
Measurable disease as defined by RECIST 1.1
ECOG performance status of 1 (see Appendix A)
Adequate bone marrow reserves as evidenced by
ANC 1,500 cells/l; and
Platelet count 100,000 cells/l; and
Hemoglobin 9 g/dL
Adequate hepatic function as evidenced by
Serum total bilirubin 1.5 ; and
AST and ALT 2.5 x ULN; and
Alkaline phosphatase 2.5 x ULN
Adequate renal function as evidenced by creatinine 1.5 x ULN
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 gemcitabine/nab- paclitaxel (including dose interruptions) and for 3 months after last dose of gemcitabine/nab-paclitaxel 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 gemcitabine/nab-paclitaxel and for 3 months following the last dose of gemcitabine/nab- paclitaxel, even if he has undergone a successful vasectomy

Exclusion Criteria

Prior chemotherapy or radiation for pancreatic cancer
CA19-9 non-expressing
Previous (within the past 5 years) or concurrent, malignancy diagnosis, except non-melanoma skin cancer and in situ carcinomas
History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
Any medical or surgical condition that may place the subject at increased risk while on study
Any condition potentially decreasing compliance to study procedures
Participation in any other clinical protocol or investigational trials within 60 days prior to Day 1, Cycle 1
Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Current abuse of alcohol or illicit drugs
Any medical condition that, in the opinion of the Investigator, may pose a safety risk to the subject, may confound the assessment of safety and efficacy, or may interfere with study participation
Have Grade 2 pre-existing peripheral neuropathy (per CTCAE)
Inability or unwillingness to sign the informed consent form
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