Trial | NCT00287768  Report issue

Title

Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer
A Phase III Study of Docetaxel and S-1 Versus S-1 in the Treatment of Advanced Gastric Cancer

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    628
The primary objective of this study is to compare median overall survival of the test arm (docetaxel and S-1) to the control arm (S-1 only) in subjects with advanced or recurrent gastric cancer.
Seven-hundred and fifty thousand of new gastric cancer cases are diagnosed worldwide per year. Advanced gastric cancer (AGC) is considered nearly incurable with less than 10% of subjects alive 5 years after diagnosis. Therefore, new treatment regimens are needed for subjects with AGC.

S-1, a new oral fluoropyrimidine which consists of the 5-FU prodrug tegafur (ftorafur, FT) and two enzyme inhibitors, CDHP (5-chloro-2,4-dihydroxypyridine) and OXO (potassium oxonate), in a molar ratio of 1(FT):0.4 (CDHP):1(OXO) is commercially available since late 90'in Japan. Phase II trials have demonstrated that S-1 is active, as a single agent, for the treatment of gastric (RR 44.6%), colorectal (RR 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers. In gastric cancer, phase III trials (JCOG 9912) comparing 5-FU alone and CPT-11/CDDP combination are currently underway and these results are awaited. Despite of JCOG 9912 study is ongoing, 80% of patients of AGC are already treated by S-1, because of high RR and convenience use for out-patient basis. P-II studies S-1/CDDP, S-1/CPT-11 and S-1/Docetaxel showed high RR(55-76%) and long MST(12-14M). Furthermore, P-III studies are already conducted S-1 vs. S-1/CDDP and S-1 vs. S-1/CPT-11 in Japan. The aim of this study is to compare S-1/Docetaxel vs. S-1 alone in the patients of AGC. This study is a prospective, multicenter, multinational, non-blinded, randomized phase III study.

Patients: Inoperable or relapse gastric cancer. Informed consent must be obtained in writing before treatment. Subjects meeting all of the inclusion criteria and exclusion criteria will be considered for enrollment into study. Then patients will be randomly assigned into two groups S-1/Docetaxel(Treatment Arm A) or S-1 alone(Treatment Arm B).
Study Started
Mar 31
2006
Primary Completion
Sep 30
2008
Study Completion
Oct 31
2010
Last Update
Jun 28
2011
Estimate

Drug docetaxel + S-1

Docetaxel iv on day one and S-1 po days 1 to 14 every 3 weeks

  • Other names: taxotere, TS-1

Drug S-1

S-1 po days 1-28 every 6 weeks

  • Other names: TS-1

1 Experimental

Docetaxel + S-1

2 Active Comparator

S-1

Criteria 

Inclusion Criteria:

Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
Subjects must be able to take orally
Measurable lesion and/or non-measurable lesion defined by RECIST
ECOG performance status ≦ 1
Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
Creatine ≦ upper normal limit (UNL)
Total bilirubin ≦ 1.5 X UNL
AST, ALT and ALP ≦ 2.5 x UNL
No prior chemotherapy
Life expectancy estimated than 3 months
Written informed consent

Exclusion Criteria:

Active double cancer
Gastrointestinal bleeding
Excessive amounts of ascites require drainage
Known brain metastases
Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
Pulmonary fibrosis, Intestinal pneumonitis
History of hypersensitivity to fluoropyrimidines, docetaxel or medications formulated with polysorbate 80
Any previous chemotherapy or radiotherapy for AGC
Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
Treatment with any investigational product during the last 4 weeks prior to study entry
Definite contraindications for the use of corticosteroids
Any subject judged by the investigator to be unfit for any reason to participate in the study
No Results Posted