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Pancreatic AdenocarcinomaPhase 1NCT03703063

Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer

A Phase 1 study testing Gemcitabine, nab paclitaxel and Onivyde 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 The sponsor has not verified this record for over two years, so it may be out of date.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 alternative neoadjuvant gemcitabine-nab-paclitaxel and nal-IRI with 5-Fluorouracil (5FU) and folinic acid (Leucovorin) regimens of localized cancer, we hope to ensure exposure of the cancer to a broader array of potentially active agents. 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, nab paclitaxel and Onivyde
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
17 Sep 2018to 17 Sep 2022
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

  • Pathologically proven resectable or borderline resectable pancreatic cancer per current NCCN criteria (http://www.nccn.org/professionals/physician_gls/f_guidelines.asp).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0/1.
  • Adequate bone marrow reserves as evidenced by:
  • absolute neutrophil count (ANC) ≥1,500 cells/μl without the use of hematopoietic growth factors; and
  • Platelet count ≥100,000 cells/μl; and
  • Hemoglobin ≥9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL).
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  • Adequate hepatic function as evidenced by:
  • Serum total bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction); and
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
  • 2.5 x upper limit of normal (ULN) (≤5 x ULN is acceptable if liver metastases are present).
  • Adequate renal function as evidenced by a serum creatinine ≤1.5 x ULN.
  • At least 18 years of age.
  • 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 study medications (including dose interruptions) and for 3 months after last dose of study medication 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 study medications and for 3 months following the last dose of study medication, even if he has undergone a successful vasectomy.

Who cannot join

  • Prior therapy for pancreatic cancer (e.g., attempted surgery, chemotherapy, radiation therapy).
  • Any contraindication to curative surgery.
  • History of any second malignancy in the last 5 years except in-situ cancer or basal or squamous cell skin cancer. Subjects with history of other malignancies are eligible if they have been continuously disease free for at least 5 years.
  • Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before study participation.
  • New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure.
  • Active infection or an unexplained fever >38.5°C during screening visit or on the first scheduled day of dosing in each cycle which, in the Investigator's opinion, might compromise the subject's participation in the trial or affect the study outcome. Subjects with tumor fever may be enrolled at the discretion of the Investigator.
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  • Known hypersensitivity to any of the components of nal-IRI, other liposomal products, fluoropyrimidines or leucovorin.
  • Neuropathy > grade 1.
  • Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
  • Any other medical or social condition deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and/or participate in the study in any way, or interfere with the interpretation of the results.
  • Inability or unwillingness to provide written informed consent.
  • Patients who are not appropriate candidates for participation in this clinical study for any other reason as determined by the investigator.

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 Picozzi, MD

    Recruiting

Other trials in United States

About this study

Official title: Alternating Neoadjuvant Gemcitabine-Nab-Paclitaxel and Nanoliposomal Irinotecan (Nal-IRI) With 5-Fluorouracil and Folinic Acid (Leucovorin) Regimens in Resectable and Borderline Resectable Pancreatic Cancer

Using alternative neoadjuvant gemcitabine-nab-paclitaxel and nal-IRI with 5-Fluorouracil (5FU) and folinic acid (Leucovorin) regimens of localized cancer, we hope to ensure exposure of the cancer to a broader array of potentially active agents. Also, potentially improves patient tolerance and minimizes significant drug toxicity that could impair delivery of all treatment elements. Furthermore, it may enable prediction of superior to inferior treatment outcomes at an earlier point in the disease progress.

Read the detailed description

This research study is a Phase Ib clinical trial. It will assess the Safety, tolerability, and feasibility of gemcitabine-nab paclitaxel alternating with nal-IRI/5FU/leucovorin (NAPOLI) in de novo resectable and borderline resectable pancreatic cancer.

Subjects must have a newly diagnosed resectable or borderline resectable pancreatic ductal cancer 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 with NAPOLI will be administered on days 1 and 15.

Being tested
Gemcitabine, nab paclitaxel, Onivyde, Leucovorin, 5-fu
Keywords
Pancreatic cancer, nal-IRI, NAPOLI
Medical subject headings
Pancreatic Neoplasms

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.

  • OnivydeDrug

    Administered by intravenous infusion over 90 minutes.

  • LeucovorinDrug

    Administered by intravenous infusion over 30 minutes.

  • 5-fuDrug

    Administered by intravenous infusion over 46 hours.

Study groups in NCT03703063
Study groupRoleWhat they receive
Resectable patientsExperimentalGemcitabine 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. Followed by nal-IRI (ONIVYDE®) 70 mg/m^2 followed by leucovorin 400 mg/m^2 followed by 5FU 2400 mg/m^2 on days 1, 15 of the 28 day cycle.
Receives: Drug: Gemcitabine; Drug: nab paclitaxel; Drug: Onivyde; Drug: Leucovorin; Drug: 5-fu
Borderline resectable patientsExperimentalGemcitabine 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. Followed by nal-IRI (ONIVYDE®) 70 mg/m^2 followed by leucovorin 400 mg/m^2 followed by 5FU 2400 mg/m^2 on days 1, 15 of the 28 day cycle.
Receives: Drug: Gemcitabine; Drug: nab paclitaxel; Drug: Onivyde; Drug: Leucovorin; Drug: 5-fu

What is being measured

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

  1. Treatment safety as assessed by CTCAE v4.03

    Toxicities are evaluated according to CTCAE v4.03

    Measured: An average of 1 year

Secondary outcomes (3)

  1. Overall survival

    OS is defined as the time between the date of enrollment and the date of death (whatever the cause).

    Measured: 5 years

  2. Progression free survival (PFS)

    PFS is defined as the time between the date of enrollment and the date of the first radiological and/or pathological progression. Progression is assessed by investigator according to RECIST v1.1 criteria.

    Measured: 5 years

  3. Response rate

    Response rate will be assessed per RECIST v1.1 criteria and CA19-9 over the entire treatment period.

    Measured: An average of 1 year

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 start17 Sep 2018
  3. Primary completion17 Sep 2021 (estimated)
  4. Study completion17 Sep 2022 (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
Non-randomised
Intervention model
Parallel groups
Model description
Resectable patients And Borderline resectable patients
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03703063
Sponsor's protocol ID
CRP17118
Status last verified
Jan 2021
First submitted
8 Oct 2018
Last updated
27 Jan 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, nab paclitaxel and Onivyde 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 14 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 27 Jan 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?

Treatment safety as assessed by CTCAE v4.03 (time frame: An average of 1 year). 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 NCT03703063.

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 27 Jan 2021.

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