- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03703089
Gemcitabine & Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology
Gemcitabine and Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology as a Sole Metastatic Site, a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Vincent J Picozzi, MD
- Phone Number: 206-223-6193
- Email: Vincent.Picozzi@virginiamason.org
Study Locations
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Washington
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Seattle, Washington, United States, 98101
- Recruiting
- Virginia Mason Medical Center
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Contact:
- Vincent J Picozzi, MD
- Phone Number: 206-223-6193
- Email: Vincent.Picozzi@virginiamason.org
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Principal Investigator:
- Vincent J Picozzi, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male, or a non-pregnant and non-lactating female.
- Age ≥ 18 years.
- Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC).
- 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).
- Laparoscopic confirmation that the PDAC is localized except for positive peritoneal cytology. Biliary stents are permitted.
- Elevated CA19-9.
- Measurable disease as defined by RECIST 1.1.
- ECOG performance status of ≤ 1 (see Appendix A).
Adequate bone marrow reserves as evidenced by:
- ANC ≥1,500 cells/μl; and
- Platelet count ≥100,000 cells/μl; and
- Hemoglobin ≥9 g/dL
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
- Adequate renal function as evidenced by creatinine ≤1.5 x ULN.
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:
- 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
- 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.
- 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:
- Prior chemotherapy or radiation for pancreatic cancer.
- CA19-9 non-expressing.
- Previous (within the past 5 years) or concurrent, malignancy diagnosis, except non-melanoma skin cancer and in situ carcinomas.
- History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies.
- Any medical or surgical condition that may place the subject at increased risk while on study.
- Any condition potentially decreasing compliance to study procedures.
- Participation in any other clinical protocol or investigational trials within 60 days prior to Day 1, Cycle 1.
- 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.
- Current abuse of alcohol or illicit drugs.
- 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.
- Have ≥ Grade 2 pre-existing peripheral neuropathy (per CTCAE).
- Inability or unwillingness to sign the informed consent form.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Administered by intravenous infusion over 30 minutes.
Other Names:
Administered by intravenous infusion over 30-40 minutes.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of cytological conversion
Time Frame: An average of 6 months
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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.
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An average of 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Up to 5 years
|
Assess progression-free survival (PFS)
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Up to 5 years
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Overall survival (OS)
Time Frame: Up to 5 years
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Assess overall survival (OS).
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Up to 5 years
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Overall response rate
Time Frame: Up to 5 years
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Assess overall response rate.
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Up to 5 years
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Response rate by CA19-9
Time Frame: An average of 1 year
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Assess response rate as measured by serial CA19-9 determinations.
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An average of 1 year
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Response rate by RECIST criteria 1.1
Time Frame: Assessment approximately every 8 weeks during treatment up to 5 years
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Assess response rate as measured by RECIST criteria 1.1 radiographic criteria.
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Assessment approximately every 8 weeks during treatment up to 5 years
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Ability to achieve R0 (complete)
Time Frame: At time of surgery, approximately 6 months after enrollment
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Assess the ability to achieve R0 (complete) resection rate in anatomically appropriate patients.
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At time of surgery, approximately 6 months after enrollment
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Local disease control rate.
Time Frame: Baseline, and approximately every 8 weeks during treatment. Up to 5 years
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Measure the local disease control rate.
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Baseline, and approximately every 8 weeks during treatment. Up to 5 years
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Pattern of disease recurrence
Time Frame: Up to 5 years
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Observe the pattern of disease recurrence (both in anatomic space and time) in the above patient population.
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Up to 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent J Picozzi, MD, Virginia Mason Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Gemcitabine
- Paclitaxel
Other Study ID Numbers
- CRP17130
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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