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

NCT03703089 | Unknown Phase 1 FDA Drug

• 1 other identifier: CRP17130
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

Positive Peritoneal Cytology

Outcome Measures

Primary Outcomes (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.

  An average of 6 months

Secondary Outcomes (8)

• Progression-free survival (PFS)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Overall response rate

  Up to 5 years

• Response rate by CA19-9

  An average of 1 year

• Response rate by RECIST criteria 1.1

  Assessment approximately every 8 weeks during treatment up to 5 years

Study Arms (1)

Gemcitabine and Nab-Paclitaxel

EXPERIMENTAL

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; Drug: nab-paclitaxel

Interventions

Gemcitabine DRUG

Administered by intravenous infusion over 30 minutes.

Also known as: GEMZAR

Gemcitabine and Nab-Paclitaxel

nab-paclitaxel DRUG

Administered by intravenous infusion over 30-40 minutes.

Also known as: Abraxane

Gemcitabine and Nab-Paclitaxel

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benaroya Research Institute: lead

Study Sites (1)

Virginia mason medical Center

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 11, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

US (1)