Clinical Trials /

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

NCT01524575

Description:

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.

Related Conditions:
  • Pancreatic Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: CRCH0904
  • NCT ID: NCT01524575

Trial Conditions

  • Metastatic Pancreatic Cancer
  • ERCC1

Trial Interventions

DrugSynonymsArms
gemcitabine and oxaliplatinERCC1 low expression

Trial Purpose

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

Trial Arms

NameTypeDescriptionInterventions
ERCC1 high expressionNo InterventionPatients with ERCC1 high expression tumors will be treated at discretion of investigator
    ERCC1 low expressionExperimentalPatients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin
    • gemcitabine and oxaliplatin

    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

    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Both
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:6 month overall survival
    Time Frame:6 months
    Safety Issue:No
    Description:

    Secondary Outcome Measures

    Measure:Overall survival
    Time Frame:Assessments every 2 months until 2 years or death
    Safety Issue:No
    Description:
    Measure:Progression free survival
    Time Frame:Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
    Safety Issue:No
    Description:
    Measure:Best confirmed response
    Time Frame:Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
    Safety Issue:No
    Description:
    Measure:Duration of overall response
    Time Frame:Assessments every 2 months with CT scan until progression by RECIST criteria up to maximum of 2 years
    Safety Issue:No
    Description:

    Trial Keywords

    • pancreatic cancer
    • ERCC1
    • oxaliplatin
    • gemcitabine