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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01524575
Recruitment Status : Withdrawn (the trial was never opened and then withdrawn permanently)
First Posted : February 2, 2012
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Hawaii

Tracking Information
First Submitted Date  ICMJE January 26, 2012
First Posted Date  ICMJE February 2, 2012
Last Update Posted Date September 25, 2019
Estimated Study Start Date  ICMJE January 2012
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
6 month overall survival [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01524575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
  • Overall survival [ Time Frame: 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 ]
  • Best confirmed response [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gemcitabine and Oxaliplatin in the Management of Metastatic Pancreatic Cancers With Low Expression of ERCC1
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Pancreatic Cancer
  • ERCC1
Intervention  ICMJE 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 Name: gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2week
Study Arms  ICMJE
  • 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
    Intervention: Drug: gemcitabine and oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 23, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2012)
50
Estimated Study Completion Date  ICMJE January 2014
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01524575
Other Study ID Numbers  ICMJE CRCH0904
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Hawaii
Study Sponsor  ICMJE University of Hawaii
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jared D Acoba, MD University of Hawaii Cancer Research Center
PRS Account University of Hawaii
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP