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

NCT04669197 | Completed Phase 2 Results FDA Drug

• 1 other identifier: HCQ NABPLAGEM-NEO 2020
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• CA 19-9 Normalization

  Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected on Day 1 of every treatment cycle (approximately 21 days/cycle); CA 19-9 normalization after 2 or more treatment cycles was measured.

  From enrollment to the end of study, up to 30 weeks.

Secondary Outcomes (7)

• Resectability Rate (R0)

  After end of treatment, from 6 months up to 2 years.

• Pathologic Complete Response Rate (pCR)

  After end of treatment, from 6 months up to 2 years.

• Radiological Response - Complete Response (CR) or Partial Response (PR)

  From enrollment to end of study, up to 30 weeks.

• Radiological Response - All Responses

  From enrollment to the end of study, up to 30 weeks.

• 2-Year Survival

  2 years after study completion

Other Outcomes (5)

• Quality of Life - Brief Pain Inventory (BPI), Pain Severity Score

  From enrollment to end of study, up to 30 weeks.

• Quality of Life - Brief Pain Inventory (BPI), Pain Interference Score

  From enrollment to end of study, up to 30 weeks.

• Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Core Symptom Severity Score

  From enrollment to end of study, up to 30 weeks.

Study Arms (1)

Treatment

OTHER

Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine

Drug: Paclitaxel protein bound; Drug: Gemcitabine; Drug: Cisplatin; Drug: Hydroxychloroquine

Interventions

Paclitaxel protein bound DRUG

combination therapy

Treatment

Gemcitabine DRUG

combination therapy

Treatment

Cisplatin DRUG

combination therapy

Treatment

Hydroxychloroquine DRUG

combination therapy

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HonorHealth Research Institute: lead

Study Sites (1)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Interventions

Taxes; Gemcitabine; Cisplatin; Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Erkut H. Borazanci, MD
• Organization: HonorHealth Research Institute

eborazanci@honorhealth.com

4805837120

Study Officials

• Erkut Borazanci, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 16, 2020
• Study Start: December 1, 2020
• Primary Completion: February 21, 2024
• Study Completion: July 31, 2025
• Last Updated: July 21, 2026
• Results First Posted: July 21, 2026

Record last verified: 2026-04

Locations

US (1)