Gemcitabine And Oxaliplatin In The Management Of Metastatic Pancreatic Cancers With Low Expression Of ERCC1

Study Overview

Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1

The goal of this clinical trial is to improve and personalize pancreatic cancer care to deliver the most effective therapy while avoiding unnecessary exposure to potential side effects. Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amounts. The hypothesis is that the combination of gemcitabine and oxaliplatin is a uniquely effective regimen for patients with metastatic pancreatic cancer whose tumors have a low expression of ERCC1.

N/A

Metastatic Pancreatic Cancer
ERCC1

DRUG: gemcitabine and oxaliplatin

CRCH0904

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 2012-01-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-09-23
First Submitted that Met QC Criteria 2012-01-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-09-25
First Posted (ACTUAL) 2012-02-02	Results First Posted N/A	Last Verified 2019-09

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:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
NO_INTERVENTION: ERCC1 high expression Patients with ERCC1 high expression tumors will be treated at discretion of investigator
EXPERIMENTAL: ERCC1 low expression Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin	DRUG: gemcitabine and oxaliplatin Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amou

Participant Group/Arm

Intervention/Treatment

NO_INTERVENTION: ERCC1 high expression

Patients with ERCC1 high expression tumors will be treated at discretion of investigator

EXPERIMENTAL: ERCC1 low expression

Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin

DRUG: gemcitabine and oxaliplatin

Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amou

Primary Outcome Measures	Measure Description	Time Frame
6 month overall survival		6 months

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival		Assessments every 2 months until 2 years or death
Progression free survival		Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Best confirmed response		Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Duration of overall response		Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years

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:

Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
Patients must not have had prior chemotherapy or biologic therapy for metastatic pancreatic cancer
Prior adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed but must have been administered > 6 months prior to registration
ECOG Performance Status of 0, 1, or 2
Adequate hematologic, hepatic and renal function

Pregnant or nursing women
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years
Patients must not have known brain metastases
Any other condition that in the opinion of the Investigator may render the patient at excessive risk for treatment complications

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Jared D Acoba, MD, University of Hawaii Cancer Research Center

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

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Resources

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Clinical Trial Record