Back to resultsStudy of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
Primary Purpose
Gastrointestinal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1 plus oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Cancer focused on measuring S-1, Oxaliplatin, Dihydropyrimidine Dehydrogenase
Eligibility Criteria
Inclusion Criteria:
- Age ≧18;
- Histologically or cytologically confirmed gastrointestinal cancer；
- ECOG ≦2;
- Physician's intention to treat with S-1 combined with platinum regimen on disease status and clinical judgment;
- Life expectancy of at least three months;
- Written informed consent to participate in the trial;
Exclusion Criteria:
- History of severe hypersensitivity reactions to the ingredients of S-1 or oxaliplatin;
Inadequate hematopoietic function which is defined as below:
- white blood cell (WBC) less than 3,500/mm^3
- absolute neutrophil count (ANC) less than 1,500/mm^3
- platelets less than 80,000/mm^3
Inadequate hepatic or renal function which is defined as below:
- serum bilirubin greater than 1.5 times the upper limit of normal range
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- greater than 2.5 times the ULN if no demonstrable liver metastases or
- greater than 5 times the ULN in the presence of liver metastases
- blood creatinine level greater than 2 times ULN
- Presence of peripheral neuropathy;
- Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug;
- Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male);
- Psychiatric disorder or symptom that makes participation of the patient difficult;
- Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months;
- Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes;
- Known DPD deficiency;
- Receiving a concomitant treatment with sorivudine or Brivudine within two months;
Sites / Locations
- Xijing hospital of the fourth military medical univercityRecruiting
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
S-1 plus oxaliplatin
Arm Description
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.
Outcomes
Primary Outcome Measures
Objective tumor response
Tumor response was evaluated by RECIST 1.1. The relationship between DPD activity and the objective tumor response will be evaluated by Cox's proportional hazards regression model.
Secondary Outcome Measures
Overall survival
The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model.
Progress-free survival
The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model.
Adverse event incidence
The relationship between DPD activity and the drug-related toxicity incidence will be evaluated by Cox's proportional hazards regression model.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01608646
Brief Title
Study of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
Official Title
Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.
Detailed Description
A new oral DPD inhibitory fluoropyrimidine (DIF), S-1, is reportedly effective against gastrointestinal carcinoma. In this study, the relationship between activity of DPD in peripheral blood and the effects of chemotherapy were investigated in 200 patients treated with first-line S-1 combined with platinum chemotherapy for gastrointestinal carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
S-1, Oxaliplatin, Dihydropyrimidine Dehydrogenase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-1 plus oxaliplatin
Arm Type
No Intervention
Arm Description
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
S-1 plus oxaliplatin
Other Intervention Name(s)
TS-1 plus oxaliplatin, Teysuno plus oxaliplatin
Intervention Description
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.
Primary Outcome Measure Information:
Title
Objective tumor response
Description
Tumor response was evaluated by RECIST 1.1. The relationship between DPD activity and the objective tumor response will be evaluated by Cox's proportional hazards regression model.
Time Frame
Every eight weeks
Secondary Outcome Measure Information:
Title
Overall survival
Description
The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model.
Time Frame
Three year
Title
Progress-free survival
Description
The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model.
Time Frame
one year
Title
Adverse event incidence
Description
The relationship between DPD activity and the drug-related toxicity incidence will be evaluated by Cox's proportional hazards regression model.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≧18;
Histologically or cytologically confirmed gastrointestinal cancer；
ECOG ≦2;
Physician's intention to treat with S-1 combined with platinum regimen on disease status and clinical judgment;
Life expectancy of at least three months;
Written informed consent to participate in the trial;
Exclusion Criteria:
History of severe hypersensitivity reactions to the ingredients of S-1 or oxaliplatin;
Inadequate hematopoietic function which is defined as below:
white blood cell (WBC) less than 3,500/mm^3
absolute neutrophil count (ANC) less than 1,500/mm^3
platelets less than 80,000/mm^3
Inadequate hepatic or renal function which is defined as below:
serum bilirubin greater than 1.5 times the upper limit of normal range
alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
greater than 2.5 times the ULN if no demonstrable liver metastases or
greater than 5 times the ULN in the presence of liver metastases
blood creatinine level greater than 2 times ULN
Presence of peripheral neuropathy;
Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug;
Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male);
Psychiatric disorder or symptom that makes participation of the patient difficult;
Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months;
Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes;
Known DPD deficiency;
Receiving a concomitant treatment with sorivudine or Brivudine within two months;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WENCHAO LIU, Professor
Phone
029-84775407
Email
liuch@FMMU.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WENCHAO LIU, professor
Organizational Affiliation
xijing hospital of the fourth military medical univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing hospital of the fourth military medical univercity
City
Xijing
State/Province
Shanxi
ZIP/Postal Code
710031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WENCHAO LIU, Professor
Phone
029-84775407
Email
liuch@FMMU.edu.cn
First Name & Middle Initial & Last Name & Degree
WENCHAO LIU, Professor
12. IPD Sharing Statement
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Study of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
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