Study Of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine As Treatment In Untreated Pancreas Cancer

Study Overview

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

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

N/A

Untreated Resectable Pancreatic Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma
Locally Advanced Pancreatic Adenocarcinoma

DRUG: Paclitaxel protein bound
DRUG: Gemcitabine
DRUG: Cisplatin
DRUG: Hydroxychloroquine

HCQ NABPLAGEM-NEO 2020

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-12-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-13
First Submitted that Met QC Criteria 2020-12-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-15
First Posted (ACTUAL) 2020-12-16	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Treatment Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine	DRUG: Paclitaxel protein bound combination therapy DRUG: Gemcitabine combination therapy DRUG: Cisplatin combination therapy DRUG: Hydroxychloroquine combination therapy

Participant Group/Arm

Intervention/Treatment

OTHER: Treatment

Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine

DRUG: Paclitaxel protein bound

combination therapy

DRUG: Gemcitabine

combination therapy

DRUG: Cisplatin

combination therapy

DRUG: Hydroxychloroquine

combination therapy

Primary Outcome Measures	Measure Description	Time Frame
Normalization Rate of CA 19-9	Evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.	6 months

Secondary Outcome Measures	Measure Description	Time Frame
Resectability Rate	Assess the resectability rate following neoadjuvant chemotherapy	6 months to 2 years
Survival Rate	Assess the 2 year survival from date of study entry	2 years
Response Rate	Assess the pathologic complete response rate and radiologic response rate	6 months to 2 years
Incidence of Treatment-Emergent Adverse Events	Assess the Grade 3 or Grade 4 related adverse events as assessed by CTCAE Version 5.0	6 months to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Erkut Borazanci, MD, HonorHealth Research Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record