Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer

NCT03703063 | Unknown Phase 1 FDA Drug

• 1 other identifier: CRP17118
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic cancer; nal-IRI; NAPOLI

Outcome Measures

Primary Outcomes (1)

• Treatment safety as assessed by CTCAE v4.03

  Toxicities are evaluated according to CTCAE v4.03

  An average of 1 year

Secondary Outcomes (3)

• Overall survival

  5 years

• Progression free survival (PFS)

  5 years

• Response rate

  An average of 1 year

Study Arms (2)

Resectable patients

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. 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.

Drug: Gemcitabine; Drug: nab paclitaxel; Drug: Onivyde; Drug: Leucovorin; Drug: 5-fu

Borderline resectable patients

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. 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.

Drug: Gemcitabine; Drug: nab paclitaxel; Drug: Onivyde; Drug: Leucovorin; Drug: 5-fu

Interventions

Gemcitabine DRUG

Administered by intravenous infusion over 30 minutes.

Also known as: Gemzar

Borderline resectable patients; Resectable patients

nab paclitaxel DRUG

Administered by intravenous infusion over 30-40 minutes.

Also known as: Abraxane

Borderline resectable patients; Resectable patients

Onivyde DRUG

Administered by intravenous infusion over 90 minutes.

Borderline resectable patients; Resectable patients

Leucovorin DRUG

Administered by intravenous infusion over 30 minutes.

Borderline resectable patients; Resectable patients

5-fu DRUG

Administered by intravenous infusion over 46 hours.

Borderline resectable patients; Resectable patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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)
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Benaroya Research Institute: lead

Study Sites (1)

Virginia mason medical Center

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Taxes; Albumin-Bound Paclitaxel; irinotecan sucrosofate; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones

Study Officials

• Vincent J Picozzi, MD

  Virginia mason medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent J Picozzi, MD

CONTACT

206-223-6193; Vincent.Picozzi@virginiamason.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Resectable patients And Borderline resectable patients

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 11, 2018
• Study Start: September 17, 2018
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2022
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)