Safety Study of Adjuvant Gemcitabine Started One Week After Laparoscopic Distal Pancreatectomy for Adenocarcinoma

October 5, 2016 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase II Study of Adjuvant Gemcitabine Started One Week After Laparoscopic

We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. This will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Gemcitabine-based chemo¬therapy remains the cornerstone for treatment of locally advanced or metastatic pancreatic cancer. Other novel chemotherapeutic combinations have been investigated in clinical trials, but the overall conclusions are that these agents have failed to improve outcomes. Our hypothesis is that nodal and hematologic micrometastasis make pancreas cancer a systemic problem at the time of surgery. Waiting the traditional six weeks to begin adjuvant therapy allows this very aggressive cancer to metastasize while the patient is waiting to begin therapy. This leads to the increased incidence of locoregional recurrence and poor prognosis. We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. This will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.

Methods: We will perform a prospective, non-randomized phase II study with patients undergoing laparoscopic distal pancreatectomy for pancreatic adenocarcinoma at Johns Hopkins Hospital. Gemcitabine will be given as a single-agent chemotherapy regimen one week following laparoscopic distal pancreatectomy according to the protocol designed by our medical oncologist. Six cycles of gemcitabine will be given. The patients will be followed in the medical oncology clinic weekly. Our Primary outcome variable will be all cause postoperative morbidity. Our sample size will be small (6-10 patients) as this is a Phase II study. Early termination rules include development of prohibitive toxicity or death. Our endpoints are an improvement in overall survival, quality of life, progression free survival, or disease free survival. Exclusion criteria will include patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

Study Type

Interventional

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
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins University School of Medicine

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients older than 18 with clinical diagnosis of distal pancreas adenocarcinoma

Exclusion Criteria:

  • Patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with distal pancreatic cancer
Patients with distal pancreatic cancer amenable to a laparoscopic distal pancreatectomy
Drug: Gemcitabine/Gemzar
Six cycles of Gemcitabine will be given. Each cycle of Gemcitabine comprises of Gemcitabine 1000 mg/m2 as a 30 minute infusion once weekly for 3 weeks with a fourth week off.
Procedure: Laparoscopic Distal pancreatectomy
Laparoscopic resection of the distal pancreas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if it is safe to administer gemcitabine to patients with pancreatic cancer one week after laparoscopic distal pancreatectomy.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the if the 1-year survival in patients with pancreatic cancer is improved with administration of gemcitabine one week following laparoscopic distal pancreatectomy
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

  • Principal Investigator: Martin A Makary, MD, MPH, Johns Hopkins University Department of Surgery

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.

General Publications

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 Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00031399

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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