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Pancreatic AdenocarcinomaPhase 1NCT03703089

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

A Phase 1 study testing Gemcitabine and nab-paclitaxel in people with Pancreatic Adenocarcinoma, run by Benaroya Research Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Gemcitabine and nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
1 May 2018to 1 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Vincent J Picozzi, MD contact

206-223-6193

Vincent.Picozzi@virginiamason.org

United States1 site, 1 recruiting

  • Virginia mason medical Center

    Seattle, Washington, 98101

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

    Vincent J Picozzi, MD

    Recruiting

Other trials in United States

About this study

Official title: Gemcitabine and Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology as a Sole Metastatic Site, a Pilot Study

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.

Read the 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.

Keywords
Positive Peritoneal Cytology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called GEMZAR

    Administered by intravenous infusion over 30 minutes.

  • nab-paclitaxelDrug

    Also called Abraxane

    Administered by intravenous infusion over 30-40 minutes.

Study groups in NCT03703089
Study groupRoleWhat they receive
Gemcitabine and Nab-PaclitaxelExperimentalParticipants 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.
Receives: Drug: Gemcitabine; Drug: nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of cytological conversion

    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.

    Measured: An average of 6 months

Secondary outcomes (8)

  1. Progression-free survival (PFS)

    Assess progression-free survival (PFS)

    Measured: Up to 5 years

  2. Overall survival (OS)

    Assess overall survival (OS).

    Measured: Up to 5 years

  3. Overall response rate

    Assess overall response rate.

    Measured: Up to 5 years

  4. Response rate by CA19-9

    Assess response rate as measured by serial CA19-9 determinations.

    Measured: An average of 1 year

  5. Response rate by RECIST criteria 1.1

    Assess response rate as measured by RECIST criteria 1.1 radiographic criteria.

    Measured: Assessment approximately every 8 weeks during treatment up to 5 years

  6. Ability to achieve R0 (complete)

    Assess the ability to achieve R0 (complete) resection rate in anatomically appropriate patients.

    Measured: At time of surgery, approximately 6 months after enrollment

  7. Local disease control rate.

    Measure the local disease control rate.

    Measured: Baseline, and approximately every 8 weeks during treatment. Up to 5 years

  8. Pattern of disease recurrence

    Observe the pattern of disease recurrence (both in anatomic space and time) in the above patient population.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2018
  2. Study start1 May 2018
  3. Primary completion1 May 2022 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03703089
Sponsor's protocol ID
CRP17130
Status last verified
Jul 2021
First submitted
8 Oct 2018
Last updated
21 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine and nab-paclitaxel in people with Pancreatic Adenocarcinoma, run by Benaroya Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vincent J Picozzi, MD (206-223-6193, Vincent.Picozzi@virginiamason.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of cytological conversion (time frame: An average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03703089.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.

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