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

Primary Purpose

Metastatic Pancreatic Cancer, ERCC1

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine and oxaliplatin
Sponsored by
University of Hawaii
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring pancreatic cancer, ERCC1, oxaliplatin, gemcitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Hawaii

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

ERCC1 high expression

ERCC1 low expression

Arm Description

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

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

Outcomes

Primary Outcome Measures

6 month overall survival

Secondary Outcome Measures

Overall survival
Progression free survival
Best confirmed response
Duration of overall response

Full Information

First Posted
January 26, 2012
Last Updated
September 23, 2019
Sponsor
University of Hawaii
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1. Study Identification

Unique Protocol Identification Number
NCT01524575
Brief Title
Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
the trial was never opened and then withdrawn permanently
Study Start Date
January 2012 (Anticipated)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer, ERCC1
Keywords
pancreatic cancer, ERCC1, oxaliplatin, gemcitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERCC1 high expression
Arm Type
No Intervention
Arm Description
Patients with ERCC1 high expression tumors will be treated at discretion of investigator
Arm Title
ERCC1 low expression
Arm Type
Experimental
Arm Description
Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine and oxaliplatin
Other Intervention Name(s)
gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2week
Intervention Description
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.
Primary Outcome Measure Information:
Title
6 month overall survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Assessments every 2 months until 2 years or death
Title
Progression free survival
Time Frame
Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Title
Best confirmed response
Time Frame
Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
Title
Duration of overall response
Time Frame
Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jared D Acoba, MD
Organizational Affiliation
University of Hawaii Cancer Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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