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Gemcitabine & Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology

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ClinicalTrials.gov Identifier: NCT03703089
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Benaroya Research Institute

Brief Summary:
Using gemcitabine and nab-paclitaxel, the investigators hope to establish the differential ability of local and cytologically positive disease to respond to this regimen, and in particular, the frequency of cytologic conversion from positive to negative in such patients. The investigators also can begin to assess the value of maximum local therapy, including surgery, in patients who cytologically convert from positive to negative.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: Gemcitabine Drug: nab-paclitaxel Phase 1

Detailed Description:

This research study is a Phase Ib clinical trial. It will assess the frequency of cytological conversion in patients with pancreatic adenocarcinoma and positive peritoneal cytology as a sole metastatic site following gemcitabine nab-paclitaxel.

Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer with positive peritoneal cytology as a sole metastatic site and meet all inclusion/exclusion criteria.

Treatment consists of 4 week treatment cycles. Nab-paclitaxel and gemcitabine will be administered on days 1,8, and 15.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine and Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology as a Sole Metastatic Site, a Pilot Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gemcitabine and Nab-Paclitaxel
Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle.
Drug: Gemcitabine
Administered by intravenous infusion over 30 minutes.
Other Name: GEMZAR

Drug: nab-paclitaxel
Administered by intravenous infusion over 30-40 minutes.
Other Name: Abraxane




Primary Outcome Measures :
  1. Frequency of cytological conversion [ Time Frame: An average of 6 months ]
    To assess the frequency of cytological conversion in patients with pancreatic adenocarcinoma and positive peritoneal cytology as a sole metastatic site following gemcitabine nab-paclitaxel.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
    Assess progression-free survival (PFS)

  2. Overall survival (OS) [ Time Frame: Up to 5 years ]
    Assess overall survival (OS).

  3. Overall response rate [ Time Frame: Up to 5 years ]
    Assess overall response rate.

  4. Response rate by CA19-9 [ Time Frame: An average of 1 year ]
    Assess response rate as measured by serial CA19-9 determinations.

  5. Response rate by RECIST criteria 1.1 [ Time Frame: Assessment approximately every 8 weeks during treatment up to 5 years ]
    Assess response rate as measured by RECIST criteria 1.1 radiographic criteria.

  6. Ability to achieve R0 (complete) [ Time Frame: At time of surgery, approximately 6 months after enrollment ]
    Assess the ability to achieve R0 (complete) resection rate in anatomically appropriate patients.

  7. Local disease control rate. [ Time Frame: Baseline, and approximately every 8 weeks during treatment. Up to 5 years ]
    Measure the local disease control rate.

  8. Pattern of disease recurrence [ Time Frame: Up to 5 years ]
    Observe the pattern of disease recurrence (both in anatomic space and time) in the above patient population.



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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. Male, or a non-pregnant and non-lactating female.
  2. Age ≥ 18 years.
  3. Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC).
  4. Radiographic and pathologic staging (including staging laparoscopy with peritoneal wash) consistent with pancreatic cancer, resectable, borderline resectable, or locally advanced or unresectable as defined by NCCN guidelines (http://www.nccn.org/professionals/physician_gls/f_guidelines.asp).
  5. Laparoscopic confirmation that the PDAC is localized except for positive peritoneal cytology. Biliary stents are permitted.
  6. Elevated CA19-9.
  7. Measurable disease as defined by RECIST 1.1.
  8. ECOG performance status of ≤ 1 (see Appendix A).
  9. Adequate bone marrow reserves as evidenced by:

    • ANC ≥1,500 cells/μl; and
    • Platelet count ≥100,000 cells/μl; and
    • Hemoglobin ≥9 g/dL
  10. Adequate hepatic function as evidenced by:

    • Serum total bilirubin 1.5 ≤; and
    • AST and ALT ≤2.5 x ULN; and
    • Alkaline phosphatase ≤2.5 x ULN
  11. Adequate renal function as evidenced by creatinine ≤1.5 x ULN.
  12. Women 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 for 28 days prior to starting gemcitabine/nab- paclitaxel (including dose interruptions) and for 3 months after last dose of gemcitabine/nab-paclitaxel and
    2. Have a negative pregnancy test result at screening and agree to ongoing pregnancy testing at the Investigator's discretion during the course of the study. This applies even if the subject practices true abstinence from heterosexual contact.
  13. Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/nab-paclitaxel and for 3 months following the last dose of gemcitabine/nab- paclitaxel, even if he has undergone a successful vasectomy.

Exclusion Criteria:

  1. Prior chemotherapy or radiation for pancreatic cancer.
  2. CA19-9 non-expressing.
  3. Previous (within the past 5 years) or concurrent, malignancy diagnosis, except non-melanoma skin cancer and in situ carcinomas.
  4. History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies.
  5. Any medical or surgical condition that may place the subject at increased risk while on study.
  6. Any condition potentially decreasing compliance to study procedures.
  7. Participation in any other clinical protocol or investigational trials within 60 days prior to Day 1, Cycle 1.
  8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  9. Current abuse of alcohol or illicit drugs.
  10. Any medical condition that, in the opinion of the Investigator, may pose a safety risk to the subject, may confound the assessment of safety and efficacy, or may interfere with study participation.
  11. Have ≥ Grade 2 pre-existing peripheral neuropathy (per CTCAE).
  12. Inability or unwillingness to sign the informed consent form.

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): NCT03703089


Contacts
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Contact: Vincent J Picozzi, MD 206-223-6193 Vincent.Picozzi@virginiamason.org

Locations
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United States, Washington
Virginia mason medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Vincent J Picozzi, MD    206-223-6193    Vincent.Picozzi@virginiamason.org   
Principal Investigator: Vincent J Picozzi, MD         
Sponsors and Collaborators
Benaroya Research Institute
Investigators
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Principal Investigator: Vincent J Picozzi, MD Virginia mason medical Center

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Responsible Party: Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT03703089     History of Changes
Other Study ID Numbers: CRP17130
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

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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
Keywords provided by Benaroya Research Institute:
Positive Peritoneal Cytology
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Albumin-Bound 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