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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 74 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 74 months
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
~140
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My nerve damage in hands/feet is mild or none.My cancer has not spread to distant parts of my body.I am fully active or restricted in physically strenuous activity but can do light work.I do not have any serious infections needing antibiotics.My pancreatic cancer can potentially be removed by surgery.My pancreatic cancer hasn't spread far and doesn't affect major arteries or veins.My pancreatic cancer is localized and affects the area near blood vessels.My pancreatic cancer hasn't spread far and doesn't affect major arteries or veins.I have a serious heart condition or recently had a heart attack.My pancreatic cancer is confirmed and can possibly be removed with surgery.My pancreatic cancer is localized but involves major blood vessels.My pancreatic cancer cannot be removed with surgery.I have not had major surgery in the last 4 weeks.I am unable or unwilling to undergo all required study biopsies and blood tests.I am currently taking a full dose of warfarin.I haven't had treatment for other cancers in the last 5 years, except for non-melanoma skin cancer or treated cervical cancer.My blood tests show normal platelet, hemoglobin, and neutrophil levels.My liver tests are within normal limits.My cancer has not spread to distant parts of my body.I have had chemotherapy or radiation for pancreatic cancer.I am older than 18 years.I am using effective birth control methods.I have a serious stomach or intestine problem.My kidney function is within the normal range.My pancreatic cancer has spread to distant parts of my body.You have a platelet count of at least 100,000 cells/mm3.Hemoglobin > 9.0 g/dL.AST and ALT are less than 2.5 times the upper limit of normal.
Research Study Groups:
This trial has the following groups:- Group 1: Nab-paclitaxel and Gemcitabine for R-PDAC
- Group 2: Nab-paclitaxel and Gemcitabine for BR-PDAC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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