Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma

February 15, 2021 updated by: Medstar Health Research Institute

A Phase 2 Study of Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma

This is a phase II study evaluating the use of intraperitoneal gemcitabine given intraoperatively and as adjuvant therapy for patients with resectable pancreas cancer.

The primary objective of this study is to evaluate the overall safety of intraperitoneal gemcitabine given intraoperatively and postoperatively for adjuvant treatment of resectable pancreatic adenocarcinoma.

The secondary objectives are to evaluate the efficacy of this treatment regimen as reflected in overall survival at 2-years, to study the patterns of disease recurrence following this treatment, to study the pharmacology of intraperitoneal gemcitabine and to study changes in peritoneal cytology with pancreatic cancer resection.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute at MedStar Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas or periampullary cancer (duodenum, ampulla of Vater or distal common bile duct).
  • Patients without a histologically confirmed diagnosis prior to surgical exploration, will have intraoperative frozen section to confirm the diagnosis prior to the administration of intraoperative intraperitoneal gemcitabine.
  • Patients must undergo adequate preoperative imaging evaluation to determine resectability including contrast enhanced CT scan or MRI with or without endoscopic ultrasound
  • Patients must have a complete surgical resection to grossly negative margins. The margins will be assessed in a routine fashion: the surgeon will decide on the level of transection based on visual inspection making sure that the visible/palpable tumor is removed with a negative margin. The specimen will be assessed for pancreatic duct and bile duct margin by intraoperative frozen section and an attempt will be made to have microscopically negative margins in all cases.
  • Patients who have not received chemotherapy for the treatment of their pancreatic cancer prior to surgery scheduled at the Washington Hospital Center may be included in the protocol.
  • Age >18 years. Because no dosing or adverse event data are currently available on the use of gemcitabine in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 2 combination trials.
  • Life expectancy of greater than 6 months
  • ECOG (Eastern Cooperative Oncology Group) performance status <2
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes >3,000/mcL
  • absolute neutrophil count >1,500/mcL
  • platelets >100,000/mcL
  • total bilirubin within normal institutional limits or compatible with preoperative biliary obstruction caused by the tumor
  • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal or compatible with preoperative biliary obstruction caused by the tumor
  • creatinine within normal institutional limits OR
  • creatinine clearance >45 mL/min
  • The effects of gemcitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to avoid pregnancy prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had radiotherapy or chemotherapy for their pancreatic cancer
  • Patients receiving any other investigational agents.
  • Patients with metastatic disease in the liver or other distant sites, intraabdominal lymph nodes beyond regional draining lymph nodes or with malignant ascites
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because gemcitabine is an antimetabolite (pyrimidine analog) with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with gemcitabine, breastfeeding should be discontinued if the mother is treated with gemcitabine. These potential risks may also apply to other agents used in this study.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with gemcitabine. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraperitoneal Gemcitabine
Drug: Intraperitoneal Gemcitabine

Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2

Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade III and IV Complications
Time Frame: Occurring during hospitalization or within 30 days of surgery, whichever is longer
Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer
Occurring during hospitalization or within 30 days of surgery, whichever is longer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Investigators

  • Principal Investigator: Lana Bijelic, MD, MedStar Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 20, 2010

First Submitted That Met QC Criteria

September 20, 2010

First Posted (Estimate)

September 21, 2010

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCI 2009-455

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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