Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD)

NCT03415854 | Completed Phase 2 FDA Drug

• 1 other identifier: SU2C HRI NPG-001
• Study Type: interventional
• Target: 11
• 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 previously untreated metastatic pancreatic cancer.

Conditions

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Pancreatic Adenocarcinoma; Pancreas Metastases; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate

  Participants will have an MRI completed after 3 cycles to determine if the tumor has responded to treatment. RECIST 1.1 criteria will be used to evaluate response. A confirmatory positron emission tomography (PET) scan may be ordered to confirm complete response.

  At the end of 3 cycles (each cycle is 21 days)

Secondary Outcomes (6)

• Carbohydrate Antigen 19-9 (CA19-9) value

  At the end of each cycle (each cycle is 21 days)

• changes in circulating biomarkers induced by paricalcitol

  At the end of each cycle (each cycle is 21 days)

• changes in circulating biomarkers induced by chemotherapy

  At the end of each cycle (each cycle is 21 days)

• pharmacodynamics effect of Paricalcitol

  At the end of 2 cycles (each cycle is 21 days)

• Parathyroid Hormone (PTH)

  At the end of each cycle (each cycle is 21 days)

Study Arms (1)

Paricalcitol (Zemplar)

EXPERIMENTAL

Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any.

Drug: Paricalcitol (Zemplar)

Interventions

Paricalcitol (Zemplar) DRUG

combination therapy

Also known as: Cisplatin (Platinol), Paclitaxel Protein Bound (Abraxane), Gemcitabine (Gemzar)

Paricalcitol (Zemplar)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years of age; male or female.
• Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
• Capable of providing informed consent and complying with trial procedures including obtaining paired biopsies during therapy
• Karnofsky Performance Status (KPS) of ≥ 70%.
• Life expectancy ≥ 12 weeks.
• Measurable tumor lesions according to RECIST 1.1 criteria.
• Women must agree not to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study and until 90 days after last dose of study treatment. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating. Both male and female patients of reproductive potential must agree to use a reliable method of birth control during the study.

You may not qualify if:

• Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the adjuvant setting with gemcitabine and/or Fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
• Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
• Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
• Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
• History of other malignancies (except cured basal or squamous cell carcinoma, superficial bladder cancer, prostate cancer in active surveillance, or carcinoma in situ of the cervix) unless documented free of cancer for ≥2 years.
• Laboratory values: Screening serum creatinine \>1.5 mg/dL; total bilirubin \> (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5x ULN or ≥ 5.0×ULN if liver metastases are present; absolute neutrophil count \<1,500/mm3, platelet concentration \<100,000/mm3, hematocrit level \<27% for females or \<30% for males, or coagulation tests (prothrombin time \[PT\], partial thromboplastin time \[PTT\], International Normalized Ratio \[INR\]) \>1.5×ULN unless on anticoagulation agents.
• Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
• History of HIV infection.
• Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or anti-fungals.
• Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.

Sponsors & Collaborators

• HonorHealth Research Institute: lead
• Barts Cancer Institute: collaborator
• Abramson Cancer Center at Penn Medicine: collaborator
• Salk Institute for Biological Studies: collaborator
• Mayo Clinic: collaborator
• Princeton University: collaborator
• Imaging Endpoints: collaborator
• Translational Genomics Research Institute: collaborator
• Stand Up To Cancer: collaborator
• Cancer Research UK: collaborator
• Lustgarten Foundation: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

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

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; 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

Study Officials

• Erkut Borazanci, MD

  HonorHealth Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 30, 2018
• Study Start: January 31, 2018
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: To be determined
• Access Criteria: The Investigator and any other study personnel involved in this study shall not disclose, or use for any purposes (other than for the performance of this study), any data, records, or other information (hereinafter collectively "information") disclosed to the Investigator or other study personnel. Such information shall remain the confidential and proprietary property of HonorHealth, and shall be disclosed only to the Investigator or other designated study personnel. The obligation of non-disclosure shall not apply to the following: * relevant disclosure to potential study participants for the purpose of obtaining informed consent; * information after such time that it is or becomes publicly available through no fault of the Investigator or other study personnel; and, * information after such time that it is disclosed to the Investigator by a third party entitled to disclose such information.

Locations

US (1)