Clinical trial NCT03726021: Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer
Official title: Clinical Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overall Survival
Keywords: overall survival; Irinotecan; Oxaliplatin; S1; Chemotherapy
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: The overall survival in this population of patients.
timeFrame: Time Frame: 2 years
Secondary outcomes:
measure: The response rate in this population of patients.
timeFrame: Time Frame: 2 years
measure: The progression free survival in this population of patients.
timeFrame: Time Frame: 2 years
measure: The toxicities in this population patients
timeFrame: Time Frame: 2 years
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao Central Hospital
Study officials:
affiliation: Qingdao Central Hospital
name: youxin ji, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nie K, Zhang L, You Y, Li H, Guo X, Zhang Z, Zhang C, Ji Y. Irinotecan combined with oxaliplatin and S-1 in patients with metastatic pancreatic adenocarcinoma: a single-arm, three-centre, prospective study. Ther Adv Med Oncol. 2020 Nov 12;12:1758835920970843. doi: 10.1177/1758835920970843. eCollection 2020.