Adjuvant Intraperitoneal Gemcitabine For Resectable Pancreatic Adenocarcinoma

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 Plan

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

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-09-20	Results First Submitted 2021-01-25	Last Update Submitted that met QC Criteria 2021-02-15
First Submitted that Met QC Criteria 2010-09-20	Results First Submitted that Met QC Criteria 2021-01-25	Last Update Posted (ACTUAL) 2021-03-09
First Posted (ACTUAL) 2010-09-21	Results First Posted 2021-02-10	Last Verified 2021-02

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Intraperitoneal Gemcitabine 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Intraperitoneal Gemcitabine

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

Primary Outcome Measures	Measure Description	Time Frame
Grade III and IV Complications	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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

Publications

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Clinical Trial Record