Untreated Resectable Pancreatic AdenocarcinomaPhase 2NCT04669197
Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydroxychloroquine as Treatment in Untreated Pancreas Cancer
A Phase 2 study testing Paclitaxel protein bound, Gemcitabine and Cisplatin in people with Untreated Resectable Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma, run by HonorHealth Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Untreated Resectable Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- Paclitaxel protein bound, Gemcitabine and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 31 Jul 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
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
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
- Being tested
- Paclitaxel protein bound, Gemcitabine, Cisplatin, Hydroxychloroquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel protein boundDrug
combination therapy
GemcitabineDrug
combination therapy
CisplatinDrug
combination therapy
combination therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine Receives: Drug: Paclitaxel protein bound; Drug: Gemcitabine; Drug: Cisplatin; Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of study, up to 30 weeks.
Secondary outcomes (7)
Resectability Rate (R0)
The percentage of participants whose tumors could be completely removed by surgery after receiving study regimen with no cancer cells left at margins (R0).
Measured: After end of treatment, from 6 months up to 2 years.
Pathologic Complete Response Rate (pCR)
Pathological complete response rate (pCR) is defined here as the absence of detectable cancer after surgical resection. Participants received a CT/MRI scan after surgical resection to monitor response using RECIST 1.1 criteria.
Measured: After end of treatment, from 6 months up to 2 years.
Radiological Response - Complete Response (CR) or Partial Response (PR)
Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria; percentage of participants reporting Complete Response (CR; all tumors disappear) and Partial Response (PR; >30% decrease in tumor size).
Measured: From enrollment to end of study, up to 30 weeks.
Radiological Response - All Responses
Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria. Complete Response (CR; all tumors disappeared), Partial Response (PR; >30% decrease in tumor size), Stable Disease (SD; no change), and Progressive Disease (PD; >20% increase in tumor size or new lesions).
Measured: From enrollment to the end of study, up to 30 weeks.
2-Year Survival
Participants were contacted by telephone every 12 weeks to monitor survival until date of death. Participants surviving up to 2 years are reported.
Measured: 2 years after study completion
Overall Survival
Participants were contacted by telephone every 12 weeks to monitor survival until date of death.
Measured: Every 12 weeks from study entry, up to 32 months.
Adverse Events Related to Study Agents
The number of patients who experienced an adverse event (AE) determined to be related to one or more of the study agents. Adverse events occurring were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Grade refers to the severity of the AE and are given on a 1-5 scale, with each scale having unique clinical descriptions of severity for each AE based on this general guideline:
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2: Moderate; minimal, local or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling.
Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Measured: From enrollment to end of study, up to 30 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Dec 2020
- Primary completion21 Feb 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Untreated Resectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erkut Borazanci, MD, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669197
- Sponsor's protocol ID
- HCQ NABPLAGEM-NEO 2020
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2020
- Last updated
- 21 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided