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

A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin+ Hydroxychlororoquine as Preoperative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas

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

Study Overview

• Status: Active, not recruiting
• Conditions: Locally Advanced Pancreatic Adenocarcinoma; Borderline Resectable Pancreatic Adenocarcinoma; Untreated Resectable Pancreatic Adenocarcinoma
• Intervention / Treatment: Drug: Cisplatin; Drug: Gemcitabine; Drug: Paclitaxel protein bound; Drug: Hydroxychloroquine

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Honorhealth Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment; Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine	Drug: Cisplatin; combination therapy; Drug: Gemcitabine; combination therapy; Drug: Paclitaxel protein bound; combination therapy; Drug: Hydroxychloroquine; combination therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: HonorHealth Research Institute
• Investigators: Principal Investigator: Erkut Borazanci, MD, Honorhealth Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): February 21, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Anti-Infective Agents; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Albumin-Bound Paclitaxel; Gemcitabine; Hydroxychloroquine; Paclitaxel
• Other Study ID Numbers: HCQ NABPLAGEM-NEO 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No