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Trial record 3 of 1973 for:    oxaliplatin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726021
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Qingdao Central Hospital

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

Condition or disease Intervention/treatment Phase
Overall Survival Drug: Irinotecan,Oxaliplatin, and S1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Clinical Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020


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,Oxaliplatin, and S1

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 Name: CPT-11/L-OHP/TS-1




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03726021


Contacts
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Contact: ketao lan, MD 84861966 kevinji78@163.com
Contact: xiaoyan wang 84861966

Locations
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China
Qingdao Central Hospital Recruiting
Qingdao, China, 266042
Contact: youxin ji, M.D.    8653268665078    mdji001@gmail.com   
Sub-Investigator: ketao lan, M.D.         
Sub-Investigator: chunling zhang, M.D.         
Principal Investigator: youxin ji, M.D.         
Sponsors and Collaborators
Qingdao Central Hospital
Investigators
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Principal Investigator: youxin ji, MD Qingdao Central Hospital

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Responsible Party: Qingdao Central Hospital
ClinicalTrials.gov Identifier: NCT03726021     History of Changes
Other Study ID Numbers: QDCH2018-10-28
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qingdao Central Hospital:
overall survival; Irinotecan; Oxaliplatin; S1; Chemotherapy
Additional relevant MeSH terms:
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Oxaliplatin
Irinotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action