Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Un… (NCT04669197) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer
United States19 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 underg…