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

NCT00202969 | Completed Phase 3

• 1 other identifier: SC101
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Stomach cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  every course for first three courses, then every other course

Secondary Outcomes (1)

• Safety profile, time to treatment failure

  any time

Study Arms (3)

1

EXPERIMENTAL

S-1

Drug: S-1

2

ACTIVE COMPARATOR

S-1 plus CDDP

Drug: S-1 plus CDDP

3

ACTIVE COMPARATOR

5-FU plus CDDP

Drug: 5-FU plus CDDP

Interventions

S-1 DRUG

S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.

1

S-1 plus CDDP DRUG

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.

2

5-FU plus CDDP DRUG

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.

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Interstitial pneumonia, pulmonary fibrosis
• Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure
• Intestinal paralysis, intestinal obstruction, uncontrollable diabetes

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

No.52 Fu-Cheng Road, Hai-dian District, Beijing Municipality, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jin Maolin, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: June 1, 2007
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

CN (1)