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

March 27, 2023 updated by: Qingdao Central Hospital

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: xiaoyan wang
  • Phone Number: 84861966

Study Locations

      • Qingdao, China, 266042
        • Qingdao Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm
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 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

Other Names:
  • CPT-11/L-OHP/TS-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The overall survival in this population of patients.
Time Frame: Time Frame: 2 years
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.
Time Frame: Time Frame: 2 years
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.
Time Frame: Time Frame: 2 years
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
Time Frame: Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2018

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

October 27, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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