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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01608646
First received: May 13, 2012
Last updated: May 28, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Cancer
Drug: S-1 plus oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Objective tumor response [ Time Frame: Every eight weeks ] [ Designated as safety issue: No ]
    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:
  • Overall survival [ Time Frame: Three year ] [ Designated as safety issue: No ]
    The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model.

  • Progress-free survival [ Time Frame: one year ] [ Designated as safety issue: No ]
    The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model.

  • Adverse event incidence [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The relationship between DPD activity and the drug-related toxicity incidence will be evaluated by Cox's proportional hazards regression model.


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608646

Contacts
Contact: WENCHAO LIU, Professor 029-84775407 liuch@FMMU.edu.cn

Locations
China, Shanxi
Xijing hospital of the fourth military medical univercity Recruiting
Xijing, Shanxi, China, 710031
Contact: WENCHAO LIU, Professor    029-84775407    liuch@FMMU.edu.cn   
Principal Investigator: WENCHAO LIU, Professor         
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: WENCHAO LIU, professor xijing hospital of the fourth military medical univercity
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01608646     History of Changes
Other Study ID Numbers: TOTTG270105
Study First Received: May 13, 2012
Last Updated: May 28, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
S-1
Oxaliplatin
Dihydropyrimidine Dehydrogenase

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014