Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer

Biliary Tract Neoplasm Clinical Trial

Official title:

Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02527824
• Other study ID #: HMC-HO-GI-1501
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 14, 2015
• Last updated: August 22, 2017
• Start date: March 2015
• Est. completion date: September 2017

Study information

• Verified date: August 2017
• Source: Hallym University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.

Description:

It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. In general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy.

S-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. So the investigators had conducted the phase I study of three drugs (oxaliplatin, irinotecan, and S-1) with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: September 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary tract system (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system)

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• More than 3 months expected life span

• Measurable lesion by RECIST criteria version 1.1

• Palliative chemotherapy naive

• Adequate organ functions

• Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

• Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer.

• Participants who had received radiation therapy for target lesions 4 weeks before study enrollment

• Participants who had received major surgery 4 weeks before study enrollment

• Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding

• Participants with central nervous system(CNS) metastases

• Participants with peripheral sensory neuropathies with impaired functional activities

• Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.

Related Conditions & MeSH terms

• Biliary Tract Neoplasm
• Biliary Tract Neoplasms

Intervention

Drug:
• Oxaliplatin, Irinotecan, S-1
Treatment will be delivered every 2 weeks Oxaliplatin 65 mg/m2 iv on day 1 Irinotecan 135 mg/m2 iv on day 1 S-1 80 mg/m2/day on day1-7

Locations

Country	Name	City	State
Korea, Republic of	Hallym university medical center	Anyang	Gyunggi

Sponsors (2)

Lead Sponsor	Collaborator
Hallym University Medical Center	Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate	Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1	1.5 year
Secondary	progression free survival	The progression-free survival (PFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause	1.5 year
Secondary	overall survival	The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method	1.5 year
Secondary	toxicity profiles - the number of participants and grade of intensity of treatment related adverse events	adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0	1.5 year