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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 74 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
R0 Resection Rates in Each Cohort as Measured by Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins
Secondary outcome measures
Median Overall Survival
Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v.4.03

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
~70
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

Academic Thoracic Oncology Medical Investigators ConsortiumLead Sponsor
4 Previous Clinical Trials
141 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,188 Total Patients Enrolled
Criterium, Inc.Industry Sponsor
16 Previous Clinical Trials
726 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02723331 — Phase 2
Pancreatic Adenocarcinoma Research Study Groups: Nab-paclitaxel and Gemcitabine for R-PDAC, Nab-paclitaxel and Gemcitabine for BR-PDAC
Pancreatic Adenocarcinoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT02723331 — Phase 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02723331 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Nab-paclitaxel and gemcitabine for use with BR-PDAC patients?

"Nab-paclitaxel and gemcitabine for BR-PDAC Patients received a safety score of 2. While there is some data indicating that the combo is safe, there are no studies yet proving its efficacy."

Answered by AI

Are Nab-paclitaxel and gemcitabine common treatments for BR-PDAC Patients?

"At present time, there are 1165 trials being run investigating Nab-paclitaxel and gemcitabine for BR-PDAC Patients. 330 of those live clinical trials are in Phase 3. While the many studies for Nab-paclitaxel and gemcitabine for BR-PDAC Patients are based in Shanghai, China, there are 59852 locations running studies for this treatment globally."

Answered by AI

Are patients who are over the age of 55 able to participate in this research?

"People aged 18 to 101 who meet the other eligibility requirements can apply to be in this clinical trial. There are 66 trials for people under 18 and 2282 trials for patients over 65."

Answered by AI

Could I potentially join this clinical trial?

"This study is seeking 50 patients with adenocarcinoma that are between 18-101 years old. To be eligible, applicants must meet the following criteria: No evidence of distant metastasis representing stage IV metastatic disease., Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma., R-PDAC: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be a clearly defined fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal"

Answered by AI

What is the primary purpose for using Nab-paclitaxel and gemcitabine on BR-PDAC patients?

"Nab-paclitaxel and gemcitabine is a combination treatment that can be used to manage neoplasm metastasis, locally advanced non-small cell lung cancer, and metastatic bladder cancer for BR-PDAC patients."

Answered by AI

How many participants are expected to enroll in this trial?

"Unfortunately, this particular trial is not currently looking for volunteers. Although, it's worth noting that there are 1146 other trials actively recruiting patients with adenocarcinoma and 1165 studies searching for Nab-paclitaxel and gemcitabine for BR-PDAC Patients."

Answered by AI

Can people with the specified medical conditions participate in this trial today?

"According to the latest information found on clinicaltrials.gov, this particular trial is not currently looking for new participants. This study was originally posted on December 30th 2016 but was updated as recently as March 8th 2022. While this research is inactive at the moment, there are 2311 other clinical trials that are still enrolling patients."

Answered by AI

In how many different locations is this trial taking place?

"The trial is currently being run by 4 different organisations including New york University, based in New York, as well as the Universities of Arizona and Colorado. Additionally, there are other sites located in 4 additional locations."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
New York University
What portion of applicants met pre-screening criteria?
Met criteria
~6 spots leftby Apr 2025