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

NCT03726021 | Completed Phase 2 DMC

• 1 other identifier: QDCH2018-10-28
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overall Survival

Keywords

overall survival; Irinotecan; Oxaliplatin; S1; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The response rate in this population of patients.

  Time Frame: 2 years

• The progression free survival in this population of patients.

  Time Frame: 2 years

• The toxicities in this population patients

  Time Frame: 2 years

Study Arms (1)

experimental arm

EXPERIMENTAL

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

Interventions

Irinotecan,Oxaliplatin, and S1 DRUG

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

Also known as: CPT-11/L-OHP/TS-1

experimental arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Qingdao Central Hospital

Qingdao, 266042, China

Location

Related Publications (1)

• 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.

  PMID: 33240399 DERIVED

MeSH Terms

Interventions

Irinotecan; Oxaliplatin; S 1 (combination)

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• youxin ji, MD

  Qingdao Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2018
• First Posted: October 31, 2018
• Study Start: January 26, 2018
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)