Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer
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|ClinicalTrials.gov Identifier: NCT04669197|
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : April 18, 2023
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|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine
Drug: Paclitaxel protein bound
- 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.
- Resectability Rate [ Time Frame: 6 months to 2 years ]Assess the resectability rate following neoadjuvant chemotherapy
- Survival Rate [ Time Frame: 2 years ]Assess the 2 year survival from date of study entry
- Response Rate [ Time Frame: 6 months to 2 years ]Assess the pathologic complete response rate and radiologic response rate
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
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.
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
|Contact: Joyce Schaffer, RN, MSN, AOCNSemail@example.com|
|United States, Arizona|
|HonorHealth Research Institute||Recruiting|
|Scottsdale, Arizona, United States, 85258|
|Contact: Clinical Trials Nurse Navigator 833-354-6667 firstname.lastname@example.org|
|Contact: Clinical Trials Nurse Navigator 480-323-1364 email@example.com|
|Principal Investigator: Erkut Borazanci, MD|
|Principal Investigator:||Erkut Borazanci, MD||HonorHealth Research Institute|
|Responsible Party:||HonorHealth Research Institute|
|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|
|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|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action