Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202969
• Other study ID #: SC101
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: July 6, 2011
• Start date: July 2005
• Est. completion date: June 2007

Study information

• Verified date: July 2011
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs >1), prior gastrectomy, and center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-prior chemotherapy treated advanced gastric adenocarcinoma

• Age 18 and over

• Performance status 0, 1, or 2 (ECOG)

• Life expectancy 3 months

• Hematopoietic WBC lower limit of normal-12,000/mm^3 Absolute granulocyte count = 2,000/mm^3 Platelet count = 100,000/mm^3 Hemoglobin = 8.0 g/dL

• Hepatic AST and ALT = 100 U/L ALP = 2 times upper limit of normal (ULN) Bilirubin = 1.5 mg/dL

• Renal Plasma creatinine = ULN Creatinine clearance = 60 mL/min

Exclusion Criteria:

• Interstitial pneumonia, pulmonary fibrosis

• Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure

• Intestinal paralysis, intestinal obstruction, uncontrollable diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.
• S-1 plus CDDP
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 21 with a single dose of CDDP 60 mg/m2 will be administered as an 1- to 3-hour IV infusion following the morning dose of S-1 on Day 8. The combination therapy will be repeated every 5 weeks.
• 5-FU plus CDDP
5-FU 600 mg/m2/24 hours administered intravenously as a CI over 120 hours (Days 1 through 5) along with a 30-minute infusion CDDP 20 mg/m2 from Day 1 through Day 5. The control treatment arm will be repeated every 4 weeks.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	No.52 Fu-Cheng Road, Hai-dian District	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		every course for first three courses, then every other course
Secondary	Safety profile, time to treatment failure		any time