Gemcitabine/Cisplatin For Resected Pancreas Cancer: Establishing The Role Of ERCC1 In Treatment Decision

Study Overview

Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision

The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer. The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.

The study will specifically be looking at ERCC1 expression in pancreas cancer with regards to its prognostic and predictive value as a biomarker for patients receiving Gem / Cis as adjuvant therapy after resection.

Pancreatic Neoplasms
Pancreatic Cancer

DRUG: Gemcitabine
DRUG: Cisplatin

IRB00034258
WCI1738-09 (OTHER Identifier) (OTHER: Other)

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	Results Reporting Dates	Study Record Updates
First Submitted 2010-07-23	Results First Submitted 2016-06-30	Last Update Submitted that met QC Criteria 2016-08-19
First Submitted that Met QC Criteria 2010-08-23	Results First Submitted that Met QC Criteria 2016-06-30	Last Update Posted (ESTIMATED) 2016-09-28
First Posted (ESTIMATED) 2010-08-25	Results First Posted 2016-08-09	Last Verified 2016-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gemcitabine / Cisplatin Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.	DRUG: Gemcitabine Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days DRUG: Cisplatin Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gemcitabine / Cisplatin

Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.

DRUG: Gemcitabine

Standard of care chemotherapy and dosage Dose - 1000 mg/m² Schedule - Days 1 and 15; Q 28 days

DRUG: Cisplatin

Dose - 50 mg/m² Schedule - Days 1 and 15; Q 28 days

Primary Outcome Measures	Measure Description	Time Frame
Recurrence-free Survival as Measured by CT Scan	Clinical data were prospectively collected. Staging was performed using 7th American Committee on Cancer criteria. Patients were followed by radiologic evaluation (CT or MRI) and carbohydrate antigen 19-9 (CA19-9) every 3 months for the first 3 years after resection to assess for recurrence. Subsequently, patients underwent imaging every 6 months.	Every 3 months and then every 6 months for 2 more years after resection

Secondary Outcome Measures	Measure Description	Time Frame
Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression	To determine the level of ERCC1 expression, formalin-fixed, resected tumors were stained with anti-ERCC1 monoclonal antibody (clone 8F1; Neomarkers, Fremont, CA, USA) using the Dako Autostainer (Ft. Collins, CO). The percentage and intensity of fine granular nuclear staining were graded by a single pathologist. Percentage of staining was categorized into the following groups: 0 ≤ 1%; 1 = 1-10%; 2 = 11-50%; 3 = 51-100%. Staining intensity was scored as follows: 0 = none; 1 = weak; 2 = moderate; 3 = strong. Subsequently, an overall score to dichotomize the expression level to low or high was calculated: [(1+intensity score)/3]*percentage score. An overall score ≤ 2 was considered low ERCC1 expression, and > 2 was high ERCC1 expression.	At the time of resection

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Shishir Maithel, MD, Emory University Winship Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record