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

NCT ID: NCT01608646

Last Updated: 2012-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2018-08-31

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.

Conditions

Gastrointestinal Cancer

Keywords

S-1; Oxaliplatin; Dihydropyrimidine Dehydrogenase

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

S-1 plus oxaliplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

TS-1 plus oxaliplatin; Teysuno plus oxaliplatin

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

WENCHAO LIU, professor

Role: PRINCIPAL_INVESTIGATOR

xijing hospital of the fourth military medical univercity

Locations

Xijing hospital of the fourth military medical univercity

Xijing, Shanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

WENCHAO LIU, Professor

Role: CONTACT

Phone: 029-84775407

Email: liuch@FMMU.edu.cn

Facility Contacts

WENCHAO LIU, Professor

Role: primary

Other Identifiers

TOTTG270105

Identifier Type: -

Identifier Source: org_study_id