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

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ClinicalTrials.gov Identifier: NCT01524575
Recruitment Status : Unknown
Verified January 2012 by University of Hawaii.
Recruitment status was:  Recruiting
First Posted : February 2, 2012
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer ERCC1 Drug: gemcitabine and oxaliplatin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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
gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2week


Outcome Measures

Primary Outcome Measures :
  1. 6 month overall survival [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Assessments every 2 months until 2 years or death ]
  2. Progression free survival [ Time Frame: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years ]
  3. Best confirmed response [ Time Frame: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years ]
  4. Duration of overall response [ Time Frame: Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524575


Contacts
Contact: Jared D Acoba, MD 8085318521 jacoba@hawaii.edu

Locations
United States, Hawaii
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jared D Acoba, MD    808-531-8521    jacoba@hawaii.edu   
Sponsors and Collaborators
University of Hawaii
Investigators
Principal Investigator: Jared D Acoba, MD University of Hawaii Cancer Research Center
More Information

Responsible Party: University of Hawaii
ClinicalTrials.gov Identifier: NCT01524575     History of Changes
Other Study ID Numbers: CRCH0904
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by University of Hawaii:
pancreatic cancer
ERCC1
oxaliplatin
gemcitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs