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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01045941
First received: December 9, 2009
Last updated: January 7, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Pancreatic Neoplasms
Drug: Gemcitabine/Gemzar
Procedure: Laparoscopic Distal pancreatectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Adjuvant Gemcitabine Started One Week After Laparoscopic

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • To determine if it is safe to administer gemcitabine to patients with pancreatic cancer one week after laparoscopic distal pancreatectomy. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 6
Study Start Date: January 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Gemcitabine/Gemzar
Procedure: Laparoscopic Distal pancreatectomy
Laparoscopic resection of the distal pancreas
Other Name: Laparoscopic distal pancreatectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01045941

Contacts
Contact: Naeem A Newman, MD 410-502-6845 nnewman4@jhmi.edu
Contact: Martin A Makary, MD,MPH 410-502-6845 mmakary1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University School of Medicine Not yet recruiting
Baltimore, Maryland, United States, 21231
Contact: Naeem A Newman, MD    410-502-6845    nnewman4@jhmi.edu   
Contact: Martin A Makary, MD,MPH    410-502-6845    mmakary1@jhmi.edu   
Sub-Investigator: Naeem A Newman, MD         
Principal Investigator: Martin A Makary, MD,MPH         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Martin A Makary, MD, MPH Johns Hopkins University Department of Surgery
  More Information

Publications:
Responsible Party: Dr. Martin Makary, Johns Hopkins University Department of Surgery
ClinicalTrials.gov Identifier: NCT01045941     History of Changes
Other Study ID Numbers: NA_00031399
Study First Received: December 9, 2009
Last Updated: January 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Distal Pancreas
Adenocarcinoma
Laparoscopic
Gemcitabine

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

ClinicalTrials.gov processed this record on August 26, 2014