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Pre-operative Treatment for Patients With Untreated Pancreatic Cancer

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. Read our disclaimer for details. Identifier: NCT03138720
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : February 17, 2022
Information provided by (Responsible Party):
HonorHealth Research Institute

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.

Condition or disease Intervention/treatment Phase
Resectable Pancreatic Cancer Unresectable Pancreatic Cancer Pancreatic Adenocarcinoma Neoadjuvant Pancreatic Cancer Drug: Paclitaxel Protein Bound (Abraxane) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: There will be two treatment groups: those who are deemed resectable and those that are deemed borderline resectable and with locally advanced pancreas cancer.
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Paricalcitol as Pre-operative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas
Actual Study Start Date : May 23, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Open Label
All patients will receive open label medication at set dosages unless the dosage needs to be adjusted to treat an adverse event or dose toxicity.
Drug: Paclitaxel Protein Bound (Abraxane)
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.
Other Names:
  • Cisplatin (Platinal
  • Gemcitabine (Gemzar)
  • Paricalcitol (Zemplar)

Primary Outcome Measures :
  1. CA19-9 value [ Time Frame: approximately 63 days ]
    Laboratory testing will be used to determine if the CA19-9 value has normalized after 3 cycles of treatment.

Secondary Outcome Measures :
  1. Pathologic Complete Response Rate [ Time Frame: approximately 63 days ]
    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 PET scan may be ordered to confirm complete response.

  2. Overall Survival [ Time Frame: every 12 weeks after study completion ]
    Participants will be contacted by telephone every 12 weeks until date of death.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT03138720

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United States, Arizona
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Sponsors and Collaborators
HonorHealth Research Institute
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Principal Investigator: Erkut Borazanci, MD HonorHealth Research Institute
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Responsible Party: HonorHealth Research Institute Identifier: NCT03138720    
Other Study ID Numbers: NABPLAGEM-NEO 2017-001
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with outside researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs