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Anti-metabolites
Neoadjuvant Chemotherapy for Pancreatic Cancer
Phase 2
Recruiting
Led By Ravi K Paluri, MD, MPH
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year after completion of study intervention
Awards & highlights
Study Summary
This trial explores the impact of using two FDA-approved chemo drugs to treat pancreatic cancer in a new sequence.
Who is the study for?
This trial is for adults with borderline resectable or locally advanced pancreatic adenocarcinoma. Participants must be in good physical condition (ECOG 0-1), have adequate organ and marrow function, and not have had prior chemotherapy for pancreatic cancer. They should understand the study and consent to participate.Check my eligibility
What is being tested?
The trial tests a sequence of chemotherapy treatments: Gemcitabine - Abraxane followed by mFOLFIRINOX, which are FDA-approved individually but not as a combined treatment for this type of cancer. The effect of this sequence on patients' conditions is being studied.See study design
What are the potential side effects?
Potential side effects include reactions to medication infusions, blood cell count changes leading to increased infection risk or bleeding problems, liver or kidney function alterations, fatigue, nausea, and other common chemotherapy-related issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year after completion of study intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year after completion of study intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
R0 Resection Rate - Borderline Resectable Prostate Cancer Participants
R0 Resection Rate - Locally Advanced Prostate Cancer Participants
Secondary outcome measures
Incidences of Adverse Events
Number of Participants to Complete Study Intervention
Overall Survival (OS)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)Experimental Treatment4 Interventions
Gemcitabine (1000 mg/m2 weekly, on day 1,8 and 15 OR 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab-paclitaxel infusion.
nab-Paclitaxel (125 mg/m2 weekly, on days 1,8, and 15 OR on days 1 and 15 as a 30-40 minute infusion administered first) for one month and then transition to mFOLFIRNIOX for one month
1 Cycle = 4 weeks: Day 1,8,15 in a 28 day cycle; 3 consecutive weeks (weeks 1, 2, and 3) of chemotherapy with 1 week off, OR
1 Cycle = 4 weeks: Day 1, 15 in a 28 day cycle; Every other week (weeks 1 and 3) of chemotherapy with 2nd and 4th week off
mFOLFIRINOX: Oxaliplatin, 85 mg/m² IV once every two weeks over 2 hours on Day 1 Irinotecan, 150 mg/m² IV once every two weeks over 90 minutes on Day 1 5-FU, 2,400 mg/m² IV once every two weeks over 46-48 hours administered via infusion Leucovorin, 400 mg/m2 IV every two weeks over 90 minutes on Day 1
Cycle = 4 weeks, administration on Day 1 and Day 15 of each mFOLIRINOX cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mFOLFIRINOX
2013
Completed Phase 2
~40
Nab paclitaxel
2014
Completed Phase 2
~70
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,377 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,666 Total Patients Enrolled
Ravi K Paluri, MD, MPHPrincipal InvestigatorWake Forest Baptist Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chemotherapy with gemcitabine, nab-paclitaxel, or FOLFIRINOX for pancreatic cancer.I haven't had cancer in the last 3 years, except for certain skin, cervical, or low-risk prostate cancers.I do not have any severe illnesses or social situations that would affect my study participation.I haven't had any major surgery in the last 4 weeks.I am fully active or can carry out light work.My blood and organ functions meet the required levels for the trial.I can understand and am willing to sign the consent form.I am 18 years old or older.I have a lung condition but don't need oxygen support.My cancer is primarily pancreatic adenocarcinoma.My pancreatic cancer is advanced but hasn't spread far and fits certain guidelines.I do not have an ongoing serious infection or have completed treatment for it.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for participants in this medical study?
"Clinicaltrials.gov states that this research trial, initially posted on the 1st of June 2023 and revised on April 19th 2023, is not presently recruiting participants. However, there are 798 other experiments searching for volunteers currently open to enrollment."
Answered by AI
Has the FDA validated Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)?
"A score of 2 was given to Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX) due to the fact that there is evidence suggesting it may be safe, yet no data proving its efficacy."
Answered by AI
What is the ultimate goal of this research endeavor?
"Through the course of this nine-month trial, researchers will be assessing the R0 Resection Rate - Locally Advanced prostate cancer Participants. Secondary observations are set to include: a count of participants that complete four cycles of sequential chemotherapy; progression-free survival (PFS) which is evaluated through RECIST v1.1 guidelines as well as overall survival (OS). Stratified Kaplan-Meier curves are employed to assess PFS and OS with estimated 6 month and median times being provided alongside 95% confidence intervals."
Answered by AI
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