Clinical Trials /

Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma

NCT02754726

Description:

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.

Related Conditions:
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Combination Therapy for Patients With Untreated Metastatic Pancreatic Ductal Adenocarcinoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: NAPPCG-EB 2015-001
  • NCT ID: NCT02754726

Conditions

  • Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

DrugSynonymsArms
NivolumabOpdivosingle arm
Albumin-bound paclitaxelAbraxanesingle arm
ParicalcitolZemplarsingle arm
Cisplatinsingle arm
GemcitabineGemzarsingle arm

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
single armOtheropen label using combination therapy
  • Nivolumab
  • Albumin-bound paclitaxel
  • Paricalcitol
  • Cisplatin
  • Gemcitabine

Eligibility 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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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

Measure: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
Safety Issue:
Description:Patients will be followed throughout their study participation and every 12 weeks following last dose of treatment until reported date of death.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:HonorHealth Research Institute

Last Updated

April 25, 2016