Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    12
  • sponsor
    HonorHealth Research Institute
Updated on 30 May 2022

Summary

To evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.

Details
Condition Untreated Resectable Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
Treatment cisplatin, Gemcitabine, hydroxychloroquine, Paclitaxel protein bound
Clinical Study IdentifierNCT04669197
SponsorHonorHealth Research Institute
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient has histologically or cytologically confirmed resectable, borderline resectable, or locally advanced (unresectable) PDAC (based upon Tempero et al 2016)
Age ≥ 18 years
If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (≥β-hCG) documented within 72 hours of the first administration of study drug
If sexually active, the patient and partner must agree to use contraception considered adequate and appropriate by the Investigator
Patient must have received no prior chemotherapy or radiation therapy for PDAC
Patients must have normal organ and marrow function
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
Karnofsky Performance Status (KPS) of ≥70%
Have an elevated CA 19-9 (>2X ULN) in the context of normal bilirubin

Exclusion Criteria

Patient will be excluded from this study if any of the following criteria apply: Evidence of metastatic disease. No metastatic disease defined as any one or more of the following; Suspicious lymphadenopathy outside of the standard surgical field (i.e. aortocaval nodes, distant abdominal nodes) or Radiographic evidence for metastatic disease in distant organs, peritoneum, or ascites
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Known infection with HIV, hepatitis B, or hepatitis C
Has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study
History of allergy or hypersensitivity to the study drugs
Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug
Current, serious, clinically significant cardiac arrhythmias as determined by the investigator
Patient is unwilling or unable to comply with study procedures
Patient is enrolled in an industry sponsored clinical trial involving treatment with investigational therapy. Patients enrolled in HonorHealth sponsored research studies may be eligible to participate as long as their participation in the other research studies does not confound the data collected for this study
Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
Use of non-FDA approved cannabinoids are prohibited. Total daily usage of up to 40 mg per day of marinol is acceptable
Exclusion Criteria for Hydroxychloroquine Expansion Cohort only
Prolonged QTcF > 450 ms for men and > 470 ms for women at Screening. Electrolyte imbalances (e.g. hypokalemia/hypomagnesemia/hypocalcemia) must be corrected prior to first dose of hydroxychloroquine
Known second or third degree atrioventricular block
Patient is taking a concomitant medication that has "known" risk of QT prolongation or torsdades de pointe
Patient has pre-existing retinopathy
Patient has known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds
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