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

September 23, 2019 updated by: University of Hawaii

Phase II Study of Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1 (Excision Repair Cross-complementation Group 1)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 amounts.
Other Names:
  • gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 month overall survival
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University of Hawaii

Investigators

  • Principal Investigator: Jared D Acoba, MD, University of Hawaii Cancer Research Center

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 Major Dates

Study Start (Anticipated)

January 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

February 2, 2012

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRCH0904

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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