Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer
Primary Purpose
Untreated Resectable Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel protein bound
Gemcitabine
Cisplatin
Hydroxychloroquine
Sponsored by

About this trial
This is an interventional treatment trial for Untreated Resectable Pancreatic Adenocarcinoma
Eligibility 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.
Sites / Locations
- HonorHealth Research Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Resectability Rate
Assess the resectability rate following neoadjuvant chemotherapy
Survival Rate
Assess the 2 year survival from date of study entry
Response Rate
Assess the pathologic complete response rate and radiologic response rate
Incidence of Treatment-Emergent Adverse Events
Assess the Grade 3 or Grade 4 related adverse events as assessed by CTCAE Version 5.0
Full Information
NCT ID
NCT04669197
First Posted
December 1, 2020
Last Updated
August 14, 2023
Sponsor
HonorHealth Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04669197
Brief Title
Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HonorHealth Research Institute
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Untreated Resectable Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine
Intervention Type
Drug
Intervention Name(s)
Paclitaxel protein bound
Intervention Description
combination therapy
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
combination therapy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
combination therapy
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
combination therapy
Primary Outcome Measure Information:
Title
Normalization Rate of CA 19-9
Description
Evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Resectability Rate
Description
Assess the resectability rate following neoadjuvant chemotherapy
Time Frame
6 months to 2 years
Title
Survival Rate
Description
Assess the 2 year survival from date of study entry
Time Frame
2 years
Title
Response Rate
Description
Assess the pathologic complete response rate and radiologic response rate
Time Frame
6 months to 2 years
Title
Incidence of Treatment-Emergent Adverse Events
Description
Assess the Grade 3 or Grade 4 related adverse events as assessed by CTCAE Version 5.0
Time Frame
6 months to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erkut Borazanci, MD
Organizational Affiliation
HonorHealth Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HonorHealth Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer
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