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

Sponsored by:	Taiho Pharmaceutical Co., Ltd.
Information provided by:	Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00202969

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer	Drug: S-1 Drug: S-1 plus CDDP Drug: 5-FU plus CDDP	Phase III

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Fluorouracil S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Response rate [ Time Frame: every course for first three courses, then every other course ]

Secondary Outcome Measures:

Safety profile, time to treatment failure [ Time Frame: any time ]

Estimated Enrollment:	180
Study Start Date:	March 2002
Study Completion Date:	December 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental S-1	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.
2: Active Comparator S-1 plus CDDP	Drug: 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.
3: Active Comparator 5-FU plus CDDP	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202969

Locations

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

Sponsors and Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

Principal Investigator:

Jin Maolin, MD

Beijing Cancer Hospital

More Information

Publications:

Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. Epub 2008 Feb 20.

Responsible Party:	Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers:	SC101
Study First Received:	September 12, 2005
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00202969 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Taiho Pharmaceutical Co., Ltd.:

Stomach cancer

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Fluorouracil
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer

Additional relevant MeSH terms:

Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site

Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009