Phase III Study of Docetaxel + S-1 vs. S-1 for Advanced Gastric Cancer

Japan Clinical Cancer Research Organization

Status and phase

Completed

Phase 3

Conditions

Gastric Cancer

Treatments

Drug: docetaxel + S-1

Drug: S-1

Study type

Interventional

Funder types

Other

Identifiers

NCT00287768

JACCRO GC-03

Details and patient eligibility

About

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.

Full description

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).

Enrollment

628 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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