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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Gastrointestinal Cancer

Treatments: Drug: S-1 plus oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01608646

TOTTG270105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

S-1 plus oxaliplatin

No Intervention group

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.

Treatment:

Drug: S-1 plus oxaliplatin