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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04669197
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
HonorHealth Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Untreated Resectable Pancreatic Adenocarcinoma Borderline Resectable Pancreatic Adenocarcinoma Locally Advanced Pancreatic Adenocarcinoma Drug: Paclitaxel protein bound Drug: Gemcitabine Drug: Cisplatin Drug: Hydroxychloroquine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  1. Resectability Rate [ Time Frame: 6 months to 2 years ]
    Assess the resectability rate following neoadjuvant chemotherapy

  2. Survival Rate [ Time Frame: 2 years ]
    Assess the 2 year survival from date of study entry

  3. Response Rate [ Time Frame: 6 months to 2 years ]
    Assess the pathologic complete response rate and radiologic response rate

  4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months to 2 years ]
    Assess the Grade 3 or Grade 4 related adverse events as assessed by CTCAE Version 5.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669197


Contacts
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Contact: Joyce Schaffer, RN, MSN, AOCNS 480-323-1364 clinicaltrials@honorhealth.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Clinical Trials Nurse Navigator    833-354-6667    clinicaltrials@honorhealth.com   
Contact: Clinical Trials Nurse Navigator    480-323-1364    clinicaltrials@honorhealth.com   
Principal Investigator: Erkut Borazanci, MD         
Sponsors and Collaborators
HonorHealth Research Institute
Investigators
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Principal Investigator: Erkut Borazanci, MD HonorHealth Research Institute
More Information
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Responsible Party: HonorHealth Research Institute
ClinicalTrials.gov Identifier: NCT04669197    
Other Study ID Numbers: HCQ NABPLAGEM-NEO 2020
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hydroxychloroquine
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Antirheumatic Agents