Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04115163

Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer

Led by Anne Noonan · Updated on 2026-02-11

67

Participants Needed

1

Research Sites

340 weeks

Total Duration

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AI-Summary

What this Trial Is About

This phase II trial studies how well a biologically optimized infusion schedule of gemcitabine and nab-paclitaxel works in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Altering the timing of the nab-paclitaxel infusion may improve response in patients with pancreatic cancer.

CONDITIONS

Official Title

Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of pancreatic adenocarcinoma with metastatic tumors measurable by CT or MRI
  • Non-pregnant and non-lactating
  • For women of childbearing potential, negative pregnancy test within 72 hours before first treatment
  • Agree to use highly effective contraception during treatment and for 3 months after
  • No previous chemotherapy or investigational therapy for metastatic pancreatic cancer; prior adjuvant treatment allowed if last chemotherapy was over 6 months ago
  • Adequate blood counts and liver function within 14 days before enrollment
  • Karnofsky performance status of 60 or higher, or ECOG performance status 0 to 2
  • Provided informed consent before study participation
Not Eligible

You will not qualify if you...

  • Known brain metastases unless treated and stable for at least 3 months
  • Active, uncontrolled infections requiring systemic therapy
  • Active HIV, hepatitis B, or hepatitis C infections (HIV patients on effective therapy with undetectable viral load within 6 months are eligible)
  • Allergy or hypersensitivity to study drugs or their components
  • Serious medical risks or psychiatric disorders affecting safety or data integrity
  • Unable or unwilling to comply with study procedures

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

CONTACT

D

Danielle Trunzo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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