The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts

This study is currently recruiting participants.
Verified November 2011 by Milton S. Hershey Medical Center
Sponsor:
Information provided by (Responsible Party):
Matthew T. Moyer, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01475331
First received: November 8, 2011
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to evaluate the efficacy of a chemotherapeutic cocktail with or without prior ethanol lavage for ablation of premalignant pancreatic cysts using endoscopic ultrasound-guided fine needle injection (EUS-FNI) for agent delivery.


Condition Intervention Phase
Mucinous Pancreatic Cysts
Drug: Ethanol
Drug: Normal Saline
Drug: Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Change in cyst volume [ Time Frame: 3, 6, and 12 months post procedure ] [ Designated as safety issue: No ]
    The primary outcome of interest will be change in cyst size, as measured on initial, 3, 6, and 12 month CT/MRI, or as determined necessary to evaluate cyst resolution


Estimated Enrollment: 78
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group Drug: Ethanol
Cysts will be lavaged for 3-5 minutes with 80% EtOH
Drug: Chemotherapy
Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.
Experimental: Study Group Drug: Normal Saline
Cysts will be lavaged for 3-5 minutes with normal saline
Drug: Chemotherapy
Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.

Detailed Description:

While about half of pancreatic cystic lesions have little to no malignant potential, mucinous cystic neoplasms (MCNs) and intraductal papillary mucinous neoplasms (IPMNs) carry a high potential for progression into pancreatic cancer. Therefore, either close radiographic surveillance or surgical resection is generally recommended for these cysts. However, pancreatic surgery is associated with a significant risk of morbidity and mortality and not all patients are good surgical candidates. As an alternative, endoscopic ultrasound-guided fine needle injection(EUS-FNI) has been shown to be moderately effective in ablating cystic lesions.

The goal of this investigation is to improve the efficacy and safety of this procedure when compared with previous versions of the technique. This study is designed to evaluate the efficacy of a chemotherapeutic cocktail with or without prior ethanol lavage for ablation of pancreatic cystic neoplasms using EUS-FNI for agent delivery. This paired, prospective, double-blind, randomized study will include 78 patients referred to the Penn State Hershey Medical Center. Mucinous or indeterminate pancreatic cysts of 1-5cm with less than 5 compartments and without clear communication with the main pancreatic duct will be included. Patients will be randomized in a 1:1 ratio into a control arm or study arm. Patients randomized to the control arm will receive ethanol lavage of the cyst followed by injection of two carefully selected chemotherapeutic agents. Study arm patients will receive a normal saline lavage followed by injection of the same chemotherapy admixture. Patients will be monitored for 2 hours post-procedure, and a follow-up CT will be performed at 3, 6, and 12 months, or as determined necessary to evaluate cyst resolution. Patients may elect to undergo evaluation for surgical resection at any time, regardless of response, in which case a dedicated pathologist will evaluate any surgical specimens.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients age 18 and older of any gender, ethnicity and race
  • Voluntary enrollment and ability to give written informed consent
  • Capable of safely undergoing endoscopy with deep sedation or general anesthesia
  • Patients with previously-detected pancreatic cyst(s) 1-5 cm in diameter, including indeterminate cysts

Exclusion Criteria:

  • Pancreatic cyst <1cm or >5cm
  • Pancreatic cyst with clear communication with main pancreatic duct
  • Clearly benign lesions by clinical and radiographic evaluation (pseudocysts and serous cystadenomas)
  • Known or suspected pancreatic cancer or pathologic lymphadenopathy
  • Septated cysts with > 5 compartments
  • Coagulopathy (international normalized ratio > 1.6, platelets < 30,000)
  • Evidence of active pancreatitis or pancreatic infection
  • Patients having undergone endoscopic retrograde cholangiopancreatography (ERCP) within 72 hours
  • Baseline lab values at the time of consent: white blood cells > 14 or < 2, hematocrit < 30, platelets < 30,000, INR > 1.6, abnormal CA19-9, lipase > 3 times the upper limit of normal, creatinine > 2.5, ALT > 210, total bilirubin > 2.5, positive qualitative beta-hCG.
  • Any pre-existing or discovered medical condition that may, at the discretion of the investigator, interfere with the completion of and/or participation in the existing protocol.
  • Pregnant, breastfeeding, or incarcerated individuals
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475331

Contacts
Contact: Matthew T Moyer, MD, MS 717-531-3694 mmoyer@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Matthew T. Moyer, MD    717-531-3694    mmoyer@hmc.psu.edu   
Principal Investigator: Matthew T. Moyer, MD         
Sub-Investigator: Brooke Ancrile, PhD         
Sub-Investigator: Thomas McGarrity, MD         
Sub-Investigator: Charles Dye, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Matthew T. Moyer, Assistant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01475331     History of Changes
Other Study ID Numbers: IRB 33751
Study First Received: November 8, 2011
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:
pancreatic cyst
chemotherapy
ethanol
ablation

Additional relevant MeSH terms:
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 14, 2014