← Back to Search

Anti-tumor antibiotic, Anti-metabolites

Chemotherapy + Alcohol Ablation for Pancreatic Cysts (CHARM Trial)

Phase 3

Recruiting

Led By Matthew T. Moyer, MD, MS

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

Capable of safely undergoing endoscopy with deep sedation or general anesthesia

Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which is consistent with a mucinous type cyst as per ASGE guidelines, including indeterminate type cysts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post initial treatment

Awards & highlights

CHARM Trial Summary

This trial will compare the effect of adding chemotherapeutic drugs to alcohol used to clean out pancreatic cysts versus just using the drugs by themselves.

Who is the study for?

Adults over 18 with a pancreatic cyst 2-5 cm in size, likely mucinous based on ASGE guidelines. Participants must be able to undergo endoscopy with sedation or anesthesia and provide consent. Excluded are those with benign cysts, suspected cancer, certain high-risk cyst features, recent pancreatitis, abnormal lab values (like blood cell counts and liver enzymes), severe medical conditions affecting life expectancy under five years, pregnant or breastfeeding women.Check my eligibility

What is being tested?

The trial is testing the effectiveness of using ethanol lavage followed by paclitaxel + gemcitabine infusion versus saline lavage plus the same chemotherapy cocktail for treating pancreatic cystic neoplasms. The treatments are delivered through an endoscopic ultrasound-guided needle.See study design

What are the potential side effects?

Potential side effects include irritation from ethanol lavage; reactions to chemotherapy like nausea, fatigue, hair loss; possible infection risk due to needle insertion; and complications from endoscopy such as bleeding or perforation.

CHARM Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I can safely undergo procedures with deep sleep or general anesthesia.

Select...

I have a pancreatic cyst between 2-5 cm, likely mucinous.

CHARM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post initial treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post initial treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post initial treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of serious and minor adverse events occurring within 30 days post ablation

Percentage of subjects achieving complete cyst resolution at 12 months

CHARM Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study groupExperimental Treatment2 Interventions

Cyst will be lavaged for 3 to 5 minutes with normal saline. Following lavage with normal saline, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).

Group II: Control GroupActive Control2 Interventions

Cyst will be lavaged for 3 to 5 minutes with >/=99% ethanol. Following lavage with >/=99% ethanol, the cyst will be infused with an admixture of (3mg/ml paclitaxel + 19mg/ml gemcitabine).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Normal saline

2013

Completed Phase 4

~2090

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,053 Total Patients Enrolled

7 Trials studying Pancreatic Cyst

13,341 Patients Enrolled for Pancreatic Cyst

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,722 Total Patients Enrolled

1 Trials studying Pancreatic Cyst

46 Patients Enrolled for Pancreatic Cyst

Matthew T. Moyer, MD, MS5.03 ReviewsPrincipal Investigator - Penn State Health Milton S Hershey Medical Center

Milton S. Hershey Medical Center

5Patient Review

I sought out Dr. Moyer for a second opinion after my original colonoscopy revealed a mass. The treating surgeon wanted to do a right hemicolectomy, but Dr. Moyer was able to remove 90% of the mass during a subsequent colonoscopy. The mass was non-cancerous, as confirmed by pathology. I'm very grateful to Dr. Moyer for his expertise and willingness to help me. I would highly recommend him to anyone in a similar situation.

Media Library

Paclitaxel + Gemcitabine admixture (Anti-tumor antibiotic, Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03085004 — Phase 3

Pancreatic Cyst Research Study Groups: Study group, Control Group

Pancreatic Cyst Clinical Trial 2023: Paclitaxel + Gemcitabine admixture Highlights & Side Effects. Trial Name: NCT03085004 — Phase 3

Paclitaxel + Gemcitabine admixture (Anti-tumor antibiotic, Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03085004 — Phase 3

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 Paclitaxel + Gemcitabine for general use?

"Paclitaxel + Gemcitabine admixture is considered safe and received a score of 3. This is because there have been multiple rounds of clinical trials testing both the efficacy and safety of this drug."

Answered by AI

What cancer has Paclitaxel + Gemcitabine been most successful in fighting?

"Paclitaxel + Gemcitabine admixture is commonly used as a treatment for obstructive hypertrophic cardiomyopathy. It can also be effective in treating multiple other conditions, such as pancreatic adenocarcinoma locally advanced, metastatic melanoma, and advanced head and neck cancer."

Answered by AI

What other research has looked into using a combination of Paclitaxel and Gemcitabine?

"The first study investigating the efficacy of Paclitaxel + Gemcitabine was completed in 1997. Since then, there have been a total of 2251 studies with 1209 currently ongoing. The majority of these live trials are taking place in Hershey, Pennsylvania."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

Matthew T. Moyer 2019. "CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03085004.