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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Metastatic Pancreatic Cancer, ERCC1

Intervention / Treatment
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* Drug: gemcitabine and oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ERCC1 high expression<br>Patients with ERCC1 high expression tumors will be treated at discretion of investigator | |
| Experimental: ERCC1 low expression<br>Patients with ERCC1 low expression will be treated with gemcitabine and oxaliplatin | Drug: gemcitabine and oxaliplatin<br>* 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.<br>* Other names: gemcitabine 1000mg/m2 IV q2week and oxaliplatin 85mg/m2 IV q2week;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 month overall survival |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic cancer, ERCC1, oxaliplatin, gemcitabine