New drug cocktail shows promise against tough pancreatic cancer
NCT ID NCT03138720
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of four drugs (paclitaxel protein bound, gemcitabine, cisplatin, and paricalcitol) given before surgery to people with pancreatic cancer that could or could not be removed. The goal was to see if the treatment could shrink tumors and improve surgical outcomes. 40 participants were enrolled, and researchers measured tumor markers and how many tumors could be completely removed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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40 people
The number who actually took part.
- Started
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May 2017
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient has histologically or cytologically confirmed resectable, borderline resectable, or locally advanced (unresectable) PDAC (based upon Tempero et al 2016) * Definition of Resectable Pancreatic Cancer includes all of the following: * No evidence of extra pancreatic disease * No evidence of tumor-arterial abutment (celiac, SMA \[superior mesenteric artery\] or HA \[hepatic artery\]) * If tumor induced narrowing of the SMV \[superior mesenteric vein\], PV \[portal vein\] or SMV-PV \[superior mesenteric-portal vein\] confluence is present, it must be \<50% of the diameter of the vessel * Definition of Borderline Resectable Pancreatic Cancer * To include at least one of the following: * Tumor abutment \<180° of the SMA or celiac axis * Tumor abutment or encasement of a short segment of the HA * Tumor induced narrowing of SMV, PV or SMV-PV of \>50% of the diameter of the vessel. * Short segment occlusion of the SMV, PV or SMV-PV with a suitable PV above and SMV below, for reconstruction * Biopsy proven N1 disease (regional lymph nodes involved) from pre-referral biopsy or EUS-guided FNA * Definition of Locally Advanced (Unresectable) * Artery: Tumor encasement (\> 180°) of SMA or celiac artery * Vein Occlusion of SMV, PV or SMV-PV without suitable vessels above and below the tumor to allow for reconstruction (no distal or proximal target for vascular reconstruction) * No extra pancreatic disease: No evidence of peritoneal, hepatic, or extra-abdominal metastases 2. Age ≥ 18 years. 3. 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 4. If sexually active, the patient and partner must agree to use contraception considered adequate and appropriate by the Investigator 5. Patient must have received no prior chemotherapy or radiation therapy for PDAC 6. Patients must have normal organ and marrow function as defined below: * absolute neutrophil count ≥ 1,500/mm3 * platelets ≥ 100,000/mm3 * Hematocrit level \> 27% * total bilirubin within institutional upper limit of normal (ULN) * AST/ALT ≤ 2.5 × institutional ULN * Alkaline phosphatase (AP) ≤ 2.5 x institutional ULN * Creatinine \< 1.5 mg/dl 7. 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. 8. Karnofsky Performance Status (KPS) of ≥70%. 9. Have an elevated CA 19-9 Exclusion Criteria: 1. 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) * Radiographic evidence for metastatic disease in distant organs, peritoneum, or ascites 2. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 3. Known infection with HIV, hepatitis B, or hepatitis C. 4. 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. 5. History of allergy or hypersensitivity to the study drugs. 6. 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. 7. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator. 8. Patient is unwilling or unable to comply with study procedures. 9. Patient is enrolled in any other therapeutic clinical protocol or investigational trial. 10. 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. 11. Use of non-FDA approved cannabinoids are prohibited. Total daily usage of up to 40 mg per day of marinol is acceptable.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
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Other studies related to the condition(s) this trial covers.
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