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Anti-metabolites

Nab-paclitaxel + Gemcitabine for Pancreatic Cancer

Phase 2

Waitlist Available

Led By Wells Messersmith, MD

Research Sponsored by Academic Thoracic Oncology Medical Investigators Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

< Grade 2 pre-existing peripheral neuropathy

R-PDAC: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery with a clearly defined fat plane between SMA and celiac axis and patent superior mesenteric vein (SMV)/portal vein (PV) with no distortion of venous architecture

Must not have

Serious, uncontrolled, concurrent infection(s) requiring antibiotics

Clinically significant cardiac disease or recent myocardial infarction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 74 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for pancreatic cancer.

Who is the study for?

Adults over 18 with resectable or borderline-resectable pancreatic cancer, without distant metastasis. They must have good performance status, adequate organ function, no prior treatments for pancreatic cancer, and agree to use contraception. Excludes those with unresectable or metastatic disease, recent major surgery, significant heart issues, uncontrolled infections or gastrointestinal disorders.

What is being tested?

The trial tests a combination of nab-paclitaxel and gemcitabine chemotherapy followed by stereotactic body radiotherapy (SBRT) on patients with operable pancreatic tumors. It aims to determine the success rate of complete tumor removal without microscopic residual disease in two patient groups: R-PDAC and BR-PDAC.

What are the potential side effects?

Potential side effects include reactions at the infusion site; low blood counts leading to increased infection risk; fatigue; nerve damage causing numbness or tingling; liver enzyme changes suggesting liver stress; digestive issues like nausea and diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My nerve damage in hands/feet is mild or none.

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My pancreatic cancer hasn't spread far and doesn't affect major arteries or veins.

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My pancreatic cancer is localized and affects the area near blood vessels.

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My pancreatic cancer is confirmed and can possibly be removed with surgery.

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My cancer has not spread to distant parts of my body.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My blood tests show normal platelet, hemoglobin, and neutrophil levels.

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My liver tests are within normal limits.

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I am older than 18 years.

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My kidney function is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious infections needing antibiotics.

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I have a serious heart condition or recently had a heart attack.

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My pancreatic cancer cannot be removed with surgery.

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I have not had major surgery in the last 4 weeks.

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I am unable or unwilling to undergo all required study biopsies and blood tests.

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I am currently taking a full dose of warfarin.

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I haven't had treatment for other cancers in the last 5 years, except for non-melanoma skin cancer or treated cervical cancer.

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I have had chemotherapy or radiation for pancreatic cancer.

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I have a serious stomach or intestine problem.

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My pancreatic cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 74 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 74 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 74 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

R0 Resection Rates in Each Cohort as Measured by Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins

Secondary study objectives

Median Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nab-paclitaxel and Gemcitabine for R-PDACExperimental Treatment2 Interventions

Nab-paclitaxel and gemcitabine, for R-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy.

Group II: Nab-paclitaxel and Gemcitabine for BR-PDACExperimental Treatment2 Interventions

Nab-paclitaxel and gemcitabine, for BR-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab paclitaxel

2014

Completed Phase 2

~580

Gemcitabine

2017

Completed Phase 3

~1920