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

This study has been withdrawn prior to enrollment.
(The study was never initiated)
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01045941
First received: December 9, 2009
Last updated: October 5, 2016
Last verified: October 2016
  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
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 ]

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 ]

Enrollment: 0
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.
Procedure: Laparoscopic Distal pancreatectomy
Laparoscopic resection of the distal pancreas

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21231
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: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01045941     History of Changes
Other Study ID Numbers: NA_00031399
Study First Received: December 9, 2009
Last Updated: October 5, 2016

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

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017