Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Washington Hospital Center
ClinicalTrials.gov Identifier:
NCT01206296
First received: September 20, 2010
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pancreatic Adenocarcinoma
Drug: Intraperitoneal Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Washington Hospital Center:

Primary Outcome Measures:
  • Grade III and IV Complications [ Time Frame: Occurring during hospitalization or within 30 days of surgery, whichever is longer ] [ Designated as safety issue: Yes ]
    Incidence of grade III and IV complications related to intraopertaive intraperitoneal gemcitabine occurring during hospitalization or within 30 days of surgery, whichever is longer


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206296

Locations
United States, District of Columbia
Washington Cancer Institute at MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Washington Hospital Center
Investigators
Principal Investigator: Lana Bijelic, MD Washington Hospital Center
  More Information

Additional Information:
No publications provided

Responsible Party: Washington Hospital Center
ClinicalTrials.gov Identifier: NCT01206296     History of Changes
Other Study ID Numbers: WCI 2009-455
Study First Received: September 20, 2010
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Washington Hospital Center:
Adjuvant
Intraperitoneal
Gemcitabine
Pancreas
Adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014