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Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02754726
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : January 6, 2020
Sponsor:
Collaborators:
Translational Genomics Research Institute
Bristol-Myers Squibb
Lustgarten Foundation
Information provided by (Responsible Party):
HonorHealth Research Institute

Study Description
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Brief Summary:
The purpose of this study is to find out if the study drugs nivolumab, albumin- bound paclitaxel, paricalcitol, cisplatin, and gemcitabine given together are safe and effective when combined to treat advanced pancreatic cancer.

Condition or disease Intervention/treatment Phase
Untreated Metastatic Pancreatic Ductal Adenocarcinoma Drug: Nivolumab Drug: Albumin-bound paclitaxel Drug: Paricalcitol Drug: Cisplatin Drug: Gemcitabine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Pilot Trial of Nivolumab + Albumin-Bound Paclitaxel + Paricalcitol + Cisplatin + Gemcitabine (NAPPCG) In Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Study Start Date : April 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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Arm Intervention/treatment
single arm
open label using combination therapy
 Drug: Nivolumab
Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
Other Name: Opdivo

Drug: Albumin-bound paclitaxel
125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Other Name: Abraxane

Drug: Paricalcitol
25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle
Other Name: Zemplar

Drug: Cisplatin
25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle

Drug: Gemcitabine
1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
Other Name: Gemzar


Outcome Measures
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Primary Outcome Measures :
  1. Complete response rate [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits.When a complete response is documented, a PET scan will be obtained to confirm.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Patients will be followed throughout their study participation and every 12 weeks following last dose of treatment until reported date of death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years of age .
  2. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
  3. Capable of providing informed consent and complying with Trial procedures.
  4. Karnofsky Performance Status (KPS) of ≥ 70%.
  5. Life expectancy ≥ 12 weeks.
  6. Measurable tumor lesions according to RECIST 1.1 criteria.
  7. Women must not be able 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. 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.

Exclusion Criteria:

  1. 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 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.
  2. Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
  3. Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
  4. Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
  5. History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
  6. Laboratory values: Screening serum creatinine > upper limit of normal (ULN); total bilirubin > (ULN); alanine aminotransferase (ALT) and AST ≥ 2.5 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 therapeutic doses of warfarin.
  7. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
  8. History of HIV infection or active or chronic hepatitis B or C.
  9. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
  10. Major surgery within 4 weeks prior to initiation of study treatment.
  11. Any condition that might interfere with the patient's participation in the study or in the evaluation of the study results.
  12. Any condition that is unstable and could jeopardize the patient's participation in the study.
  13. Patient has a transplanted organ.
  14. Patients with a history of autoimmune disease.
  15. Prior PD-1 or PD-L1 therapy.
  16. Patients taking any chemo or immunosuppressive steroids (equivalent to > 20 mg hydrocortisone per day).
  17. Patients cannot have > Grade 1 pre-existing peripheral neuropathy (per CTCAE).
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02754726


Contacts
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Contact: Joyce Schaffer, MSN, AOCNS 480-323-1339 (option #2) Joyce.Schaffer@HonorHealth.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN, AOCNS    480-323-1339 ext option #2    Joyce.Schaffer@HonorHealth.com   
Principal Investigator: Erkut Borazanci, MD         
Sponsors and Collaborators
HonorHealth Research Institute
Translational Genomics Research Institute
Bristol-Myers Squibb
Lustgarten Foundation
Investigators
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Principal Investigator: Erkut Borazanci, MD HonorHealth Research Institute
More Information
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Responsible Party: HonorHealth Research Institute
ClinicalTrials.gov Identifier: NCT02754726    
Other Study ID Numbers: NAPPCG-EB 2015-001
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Nivolumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological