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

Phase 2
18 Years
Open (Enrolling)
Pancreatic Adenocarcinoma

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Trial Information

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

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma of the
pancreas or periampullary cancer (duodenum, ampulla of Vater or distal common bile

- 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

- 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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Grade III and IV Complications

Outcome Description:

Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer

Outcome Time Frame:

Occurring during hospitalization or within 30 days of surgery, whichever is longer

Safety Issue:


Principal Investigator

Lana Bijelic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington Hospital Center


United States: Food and Drug Administration

Study ID:

WCI 2009-455



Start Date:

August 2010

Completion Date:

December 2015

Related Keywords:

  • Pancreatic Adenocarcinoma
  • Adjuvant
  • Intraperitoneal
  • Gemcitabine
  • Pancreas
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Washington Cancer Institute at Washington Hospital Center Washington, District of Columbia  20010