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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Drug: S-1 plus oxaliplatin

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: WENCHAO LIU, Professor; Phone Number: 029-84775407; Email: liuch@FMMU.edu.cn

Study Locations

• China
  • Shanxi
    • Xijing, Shanxi, China, 710031
      • Recruiting
      • Xijing hospital of the fourth military medical univercity
      • Contact: WENCHAO LIU, Professor; Phone Number: 029-84775407; Email: liuch@FMMU.edu.cn
      • Principal Investigator: WENCHAO LIU, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.	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.; Other Names: TS-1 plus oxaliplatin; Teysuno plus oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model.	Three year
Progress-free survival	The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model.	one year
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: WENCHAO LIU, professor, Xijing hospital of the fourth military medical univercity

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: May 13, 2012
• First Submitted That Met QC Criteria: May 28, 2012
• First Posted (Estimate): May 31, 2012

Study Record Updates

• Last Update Posted (Estimate): May 31, 2012
• Last Update Submitted That Met QC Criteria: May 28, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: S-1; Oxaliplatin; Dihydropyrimidine Dehydrogenase
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: TOTTG270105