Pre-operative Treatment for Patients With Untreated Pancreatic Cancer

NCT03138720 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NABPLAGEM-NEO 2017-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the combination of paclitaxel protein bound, gemcitabine, cisplatin, paricalcitol are effective in individuals with resectable and unresectable pancreatic cancer.

Conditions

Resectable Pancreatic Cancer; Unresectable Pancreatic Cancer; Pancreatic Adenocarcinoma; Neoadjuvant Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• CA 19-9 Normalization

  Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected after every treatment cycle (approximately 3 weeks/cycle); CA 19-9 normalization after 3 or more treatment cycles was measured.

  From enrollment to the end of treatment, up to 26 weeks.

Secondary Outcomes (5)

• Resectability Rate (R0)

  From enrollment to the end of treatment, up to 26 weeks.

• Pathologic Complete Response Rate (pCR)

  From enrollment to end of treatment, up to 26 weeks.

• Radiological Response - All Responses

  From enrollment to the end of treatment, up to 26 weeks.

• Radiological Response - Complete Response (CR) or Partial Response (PR)

  From enrollment to the end of treatment, up to 26 weeks.

• Overall Survival

  every 12 weeks after study completion

Other Outcomes (5)

• Quality of Life - Brief Pain Inventory (BPI), Pain Severity Score

  From enrollment to end of study, up to 26 weeks.

• Quality of Life - Brief Pain Inventory (BPI), Pain Interference Score

  From enrollment through end of study, up to 26 weeks.

• Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Core Symptom Severity Score

  From enrollment to end of study, up to 26 weeks.

Study Arms (2)

Cohort A: Resectable

EXPERIMENTAL

Participants with resectable pancreatic cancer are assigned to Cohort A (see Protocol for definitions). Participants are offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. Participants whose CA19-9 levels normalize during the above neoadjuvant therapy will be re-evaluated for surgery and removed from study for surgical resection if determined eligible.

Drug: Paclitaxel Protein Bound (Abraxane)

Cohort B: Borderline Resectable/Locally Advanced (Unresectable)

EXPERIMENTAL

Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer are assigned to Cohort B (see Protocol for definitions). Participants are offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. Participants whose CA19-9 levels normalize during the above neoadjuvant therapy will be re-evaluated for surgery and removed from study for surgical resection if determined eligible.

Drug: Paclitaxel Protein Bound (Abraxane)

Interventions

Paclitaxel Protein Bound (Abraxane) DRUG

Participants will be treated with the regimen prior to having surgery. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization. If CA19-9 is normalized, then participant will be scheduled for surgery and moved to standard of care. If CA19-9 is not normalized then participants will complete another 3 cycles.

Also known as: Gemcitabine (Gemzar), Paricalcitol (Zemplar), Cisplatin (Platinol)

Cohort A: Resectable; Cohort B: Borderline Resectable/Locally Advanced (Unresectable)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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 any other therapeutic clinical protocol or investigational trial.
• 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.

Sponsors & Collaborators

• HonorHealth Research Institute: lead

Study Sites (1)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Interventions

Taxes; Albumin-Bound Paclitaxel; Gemcitabine; paricalcitol; Cisplatin

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

The COVID-19 pandemic imposed restrictions at the study site and impacted study conduct. Accordingly, Investigators allowed flexibility in study visit schedules that were captured as protocol deviations. Additional limitations: (1) a suboptimal EDC design which affected data collection; (2) incomplete monitoring/delays in SAE reconciliation requiring corrective actions. These factors collectively contributed to missed study procedures and delays in data monitoring/finalization of study results.

Results Point of Contact

• Title: Erkut Borazanci, MD
• Organization: HonorHealth Research Institute

eborazanci@honorhealth.com

480-583-7120

Study Officials

• Erkut Borazanci, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be two treatment groups: those who are deemed resectable and those that are deemed borderline resectable and with locally advanced pancreas cancer.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: May 23, 2017
• Primary Completion: July 13, 2023
• Study Completion: November 3, 2025
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)