Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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To identify the efficiency of Irinotecan, Oxaliplatin, and S1 in patients with previously untreated local regional or metastatic pancreatic cancer.

Detailed Description
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This research study is a Phase 2 clinical trial. It will test the efficiency and safety of an investigational drug f Irinotecan,Oxaliplatin, and S1, with the goal of determining the OS of advanced pancreatic adenocarcinoma.. Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer and meet all inclusion/exclusion criteria. Treatment consists of treatment with Irinotecan 165mg/m2, Oxaliplatin 85mg/m2 on day 1, and S1 40mg orally on day 1-14, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.

Official Title
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Clinical Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer

Conditions
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Overall Survival

Intervention / Treatment
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* Drug: Irinotecan,Oxaliplatin, and S1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Cytologically- or histologically-confirmed pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites. Other histologies such as neuroendocrine and acinar cell carcinoma are excluded. No prior chemotherapy for locally advanced or metastatic pancreatic cancer. Patients are eligible if they received adjuvant treatment after surgical resection Participants are required to have measurable disease (RECIST v1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan. See section 11 for the evaluation of measurable disease. Participants enrolled must have disease that is accessible for tumor biopsies and must agree to a pre-treatment tumor biopsy. Age ≥ 18 years. Because no dosing or adverse event data are currently available in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials. ECOG performance status ≤2 (see Appendix A) Patients must have completed any major surgery or open biopsy ≥4 weeks from start of treatment. Participants must have adequate organ and marrow function as defined below: Absolute neutrophil count ≥1,500/mcL Platelets ≥100,000/mcL Total bilirubin ≤1.5 × institutional upper limit of normal AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal Creatinine ≤1.5 × institutional upper limit of normal OR Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 × upper limit of normal. Negative serum pregnancy test for women of childbearing potential. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: • Prior chemotherapy or any other investigational agents for the treatment of locally advanced or metastatic pancreatic cancer Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents. Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Screening for brain metastases with head imaging is not required. History of allergic reactions attributed to compounds of similar chemical or biologic composition to above drugs or other agents used in study. History of prior or current synchronous malignancy, except: o Malignancy that was treated with curative intent and for which there has been no known active disease for >3 years prior to enrollment Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, NYHA class III/IV congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Interventional Model Description: Experimental: Irinotecan,Oxaliplatin, and S1 S1 will be administered orally days 1 and 14 of a 21 day cycle Irrinotecan 165 mg/m2 and Oxaliplatin 85mg/m2 will be administered IV days 1 of a 21 day cycle.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br>Treatment consists of treatment with Irinotecan 165mg/m2, Oxaliplatin 85mg/m2 on day 1, and S1 40mg orally on day 1-14, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study. | Drug: Irinotecan,Oxaliplatin, and S1<br>* Drug: Irinotecan is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells. Drug: Oxalipatin Oxaliplatin is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells Drug: S1 is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells<br>* Other names: CPT-11/L-OHP/TS-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall survival in this population of patients. | The overall survival of the enrolled patients from start the combination treatment of Irinotecan, Oxaliplatin, and S1. | Time Frame: 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The response rate in this population of patients. | Number of participants with clinical response assessed by RECIST 1.1 criteria on imaging every 4 weeks with the combination of Irinotecan,Oxaliplatin, and S1. | Time Frame: 2 years | 
| The progression free survival in this population of patients. | The progression free survival of the enrolled patients from start the combination treatment with Irinotecan,Oxaliplatin, and S1. | Time Frame: 2 years | 
| The toxicities in this population patients | Adverse events were recorded and classified from start the treatment by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. | Time Frame: 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overall survival; Irinotecan; Oxaliplatin; S1; Chemotherapy