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

Phase 2

• Conditions: Gastrointestinal Cancer
• Interventions: Drug: S-1 plus oxaliplatin

• Registration Number: NCT01608646
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-13
• Study First Submitted QC: 2012-05-28
• Last Update Submitted: 2012-05-28
• Study First Posted: 2012-05-31
• Last Update Posted: 2012-05-31
• Primary Completion: 2013-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-1 plus oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Objective tumor response	Every eight weeks	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

Name	Time	Method
Overall survival	Three year	The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model.
Progress-free survival	one year	The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model.
Adverse event incidence	One year	The relationship between DPD activity and the drug-related toxicity incidence will be evaluated by Cox's proportional hazards regression model.

Trial Locations

Locations (1)

Xijing hospital of the fourth military medical univercity; 🇨🇳 Xijing, Shanxi, China