Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel
cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.
Phase
Phase 2
Funding Agency/Sponsor
Institutional
Disease
Pancreatic, Liver, and Related Cancers
Enrollment Eligibility
Inclusion Criteria:
1. Age ≥ 18 years of age; male or female
2. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
3. Capable of providing informed consent and complying with trial procedures.
4. Karnofsky Performance Status (KPS) of ≥ 70%.
5. Life expectancy ≥ 12 weeks.
6. Measurable tumor lesions according to RECIST 1.1 criteria.
7. < Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0
8. Patient has acceptable coagulation status as indicated by an INR ≤1.5 x ULN. Patients
on anticoagulation can be included at the discretion of the investigator.
9. Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/mm3
- Platelet concentration ≥100,000/mm3 with no platelet transfusions within 7 days
prior to laboratory sample
- Hemoglobin > 9.0g/dL
- Hematocrit level > 27%
- Total bilirubin within 1.25 times institutional upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and AST < 10 × institutional ULN
- Serum creatinine <1.5 mg/dl
10. Females 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:
1. 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, 28 days prior to starting IP
therapy (including dose interruptions), and while on study medication or for a
longer period if required by local regulations following the last dose of IP; and
2. Have a negative serum pregnancy test (β -hCG) result at screening and agree to
ongoing pregnancy testing during the course of the study, and after the end of
study therapy. This applies even if the subject practices true abstinence* from
heterosexual contact.
11. Male subjects must practice true abstinence* or agree to use a condom during sexual
contact with a pregnant female or a female of childbearing potential while
participating in the study, during dose interruptions and for 6 months following
discontinuation from study treatment, even if he has undergone a successful vasectomy.
Exclusion Criteria:
1. Patients must have received no previous radiotherapy, surgery, chemotherapy or
investigational therapy for the treatment of metastatic disease. Prior treatments in
the neoadjuvant and/or adjuvant setting with gemcitabine and/or 5-FU based therapies
or gemcitabine and/or 5FU administered as a radiation sensitizer are allowed, provided
at least 6 months have elapsed since completion of the last dose and no lingering
toxicities are present.
2. Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of
study treatment.
3. Exposure to any investigational agent within 4 weeks prior to initiation of study
treatment.
4. Evidence of central nervous system (CNS) metastasis (negative imaging study, if
clinically indicated, within 4 weeks of Screening Visit).
5. History of other malignancies (except cured basal cell carcinoma, superficial bladder
cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥5
years.
6. Current, serious, clinically significant cardiac arrhythmias as determined by the
investigator.
7. History of HIV infection.
8. Active, clinically significant serious infection requiring treatment with antibiotics,
anti-virals or anti-fungals.
9. Major surgery within 4 weeks prior to initiation of study treatment.
10. Any condition in the opinion of the principal investigator that might interfere with
the patient's participation in the study or in the evaluation of the study results.
11. Any condition in the opinion of the principal investigator that is unstable and could
jeopardize the patient's participation in the study.