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

• Sponsor: Xijing Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01608646
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Duration (Months): 77
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer	Drug: S-1 plus oxaliplatin	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
• Study Start Date: Mar 1, 2012
• Anticipated Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Aug 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Overall survival [Three year]

   The relationship between DPD activity and the overall survival will be evaluated by Cox's proportional hazards regression model.

2. Progress-free survival [one year]

   The relationship between DPD activity and the PFS will be evaluated by Cox's proportional hazards regression model.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Xijing hospital of the fourth military medical univercity	Xijing	Shanxi	China	710031

Sponsors and Collaborators

• Xijing Hospital

Investigators

• Principal Investigator: WENCHAO LIU, professor, xijing hospital of the fourth military medical univercity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xijing Hospital
• ClinicalTrials.gov Identifier: NCT01608646
• Other Study ID Numbers: TOTTG270105
• First Posted: May 31, 2012
• Last Update Posted: May 31, 2012
• Last Verified: May 1, 2012

• Keywords provided by Xijing Hospital: S-1; Oxaliplatin; Dihydropyrimidine Dehydrogenase
• Additional relevant MeSH terms: Gastrointestinal Neoplasms; Oxaliplatin

Study Results

No Results Posted as of May 31, 2012