Study of DPD for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer

Gastrointestinal Cancer Clinical Trial

Official title:

Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01608646
• Other study ID #: TOTTG270105
• Status: Recruiting
• Phase: Phase 2
• First received: May 13, 2012
• Last updated: May 28, 2012
• Start date: March 2012
• Est. completion date: August 2018

Study information

• Verified date: May 2012
• Source: Xijing Hospital
• Contact: WENCHAO LIU, Professor
• Phone: 029-84775407
• Email: liuch[@]FMMU.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2018
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Drug:
• S-1 plus oxaliplatin
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.

Locations

Country	Name	City	State
China	Xijing hospital of the fourth military medical univercity	Xijing	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every eight weeks	No
Secondary	Overall survival	The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model.	Three year	No
Secondary	Progress-free survival	The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model.	one year	No
Secondary	Adverse event incidence	The relationship between DPD activity and the drug-related toxicity incidence will be evaluated by Cox's proportional hazards regression model.	One year	Yes