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

Phase 2

Withdrawn

• Conditions: Pancreatic Neoplasms
• Interventions: Drug: Gemcitabine/Gemzar; Procedure: Laparoscopic Distal pancreatectomy

• Registration Number: NCT01045941
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

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.

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 Timeline

• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with distal pancreatic cancer	Gemcitabine/Gemzar	Patients with distal pancreatic cancer amenable to a laparoscopic distal pancreatectomy
Patients with distal pancreatic cancer	Laparoscopic Distal pancreatectomy	Patients with distal pancreatic cancer amenable to a laparoscopic distal pancreatectomy

Primary Outcome Measures

Name	Time	Method
To determine if it is safe to administer gemcitabine to patients with pancreatic cancer one week after laparoscopic distal pancreatectomy.	1 year

Secondary Outcome Measures

Name	Time	Method
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	1 year

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States