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Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic 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: NCT03915444
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
HonorHealth Research Institute

Study Description
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Brief Summary:
This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: nab-Paclitaxel + Cisplatin + Gemcitabine Phase 2

Detailed Description:

This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.

An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles may be administered until the patient is withdrawn from therapy.

Overall response rates as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST 1.1 (Frese 2012). Time-to-event endpoints, including PFS and OS will be assessed using the Kaplan-Meier method (Kaplan 1958). Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 5.0.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : April 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NabCG
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
 Drug: nab-Paclitaxel + Cisplatin + Gemcitabine

Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days.

Gemcitabine 1000mg/m2 in 500 mL* over 30 minute IV infusion on days 1 and 8 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 on days 1 and 8 repeated every 21 days.

Other Name: NabCG


Outcome Measures
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Primary Outcome Measures :
  1. 12- Month Overall Survival [ Time Frame: 360 days ]
    Evaluate the 12-month OS rate in patients with metastatic PDA treated with nab-paclitaxel plus cisplatin plus gemcitabine


Secondary Outcome Measures :
  1. Change in tumor markers [ Time Frame: 63 days ]
    To determine the preliminary efficacy (Disease control rate of CR+ PR+SD X 9 weeks) of the combination of nanoparticle albumin- bound paclitaxel + cisplatin + gemcitabine (NABPLAGEM) in patients with stage IV metastatic pancreatic cancer.complete response rate( RECIST 1.1), disease control rate at 9 weeks, Change and rates of normalization in CA 19-9 (or Ca125 or CEA if not expressers of CA 19-9)

  2. Quality of Life: MD Anderson Symptom Inventory (MDASI-GI) [ Time Frame: 63 days ]
    Changes in patient's self-reported quality of life will be determined by administering the MD Anderson Symptom Inventory (MDASI-GI). This questionnaire asks about severity of symptoms using numbers (0 = not present to 10 = as bad as you can imagine).

  3. Pain Control: Brief Pain Inventory (BPI) [ Time Frame: 63 days ]
    Changes in patient's self-reported pain levels will be determined by administering the Brief Pain Inventory (BPI). This form asks about severity of pain using numbers (0 = not present to 10 = as bad as you can imagine).

  4. Potential tumor biomarkers [ Time Frame: 63 days ]
    Tumor biopsy testing will be completed to evaluate potential biomarkers in the tumor to evaluate various copy number variant signatures

  5. Disease Response [ Time Frame: 63 days ]
    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 (from at least > 2X ULN).


Eligibility Criteria
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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 to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years of age; male or female
  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. < Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0
  8. 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.

  9. Patients must have normal organ and marrow function as defined below:

    • Absolute neutrophil count ≥1,500/mm3
    • Platelet concentration ≥100,000/mm3 with no platelet transfusions within 7 days prior to laboratory sample
    • Hemoglobin > 9.0g/dL
    • Hematocrit level > 27%
    • Total bilirubin within 1.25 times institutional upper limit of normal (ULN)
    • Alanine aminotransferase (ALT) and AST < 10 × institutional ULN
    • Serum creatinine <1.5 mg/dl

  10. Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:

    1. Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP; and
    2. Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact.
  11. Male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following discontinuation from study treatment, even if he has undergone a successful vasectomy.

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 neoadjuvant and/or adjuvant setting with gemcitabine and/or 5-FU based therapies or gemcitabine and/or 5FU 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. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
  7. History of HIV infection.
  8. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
  9. Major surgery within 4 weeks prior to initiation of study treatment.
  10. Any condition in the opinion of the principal investigator that might interfere with the patient's participation in the study or in the evaluation of the study results.
  11. Any condition in the opinion of the principal investigator that is unstable and could jeopardize the patient's participation in the study.
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): NCT03915444


Contacts
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Contact: Joyce Schaffer 480-323-1791 joschaffer@honorhealth.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN, AOCNS         
Principal Investigator: Gayle S Jameson, MSN, ACNP-BC, AOCN         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Peter Hosein, MD       mailto:phosein@med.miami.edu   
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Erin Pierce, NP       erin.pierce@ochsner.org   
United States, Wisconsin
Froedtert & Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Mandana Kamgar, MD       mkamgar@mcw.edu   
Sponsors and Collaborators
HonorHealth Research Institute
Celgene
Investigators
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Principal Investigator: Gayle Jameson, ACNP-BC HonorHealth Research Institute
More Information
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Responsible Party: HonorHealth Research Institute
ClinicalTrials.gov Identifier: NCT03915444    
Other Study ID Numbers: AX-CL-PANC-PI-13301
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
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