advanced gastric cancer
Conditions
Interventions
TAS-102 (35 mg/m2/dose BID) is administered orally on Day1-5 and Day8-12 in 28-day cycles.
Sponsors
National Cancer Center Hospital East
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma. 2) Inoperable, recurrent or metastatic disease. 3) Tumor progression during prior chemotherapy or within 2 months after prior chemotherapy. 4) >= 20 years old. 5) ECOG performance status of <= 2. 6) Measurable disease without irradiation according to RECIST ver1.1. 7) Prior chemotherapies for advanced gastric cancer are as follows. (In case of progression during adjuvant/neoadjuvant therapy or <= 6 months after the last administration of adjuvant/neoadjuvant therapy, the adjuvant/neoadjuvant therapy will be considered one prior treatment.) i. Include chemotherapy with 5-FU. ii. Include chemotherapy with platinum derivative. iii. Include chemotherapy with taxane or irinotecan. iv. No. of prior chemotherapies <= 2. 8) Adequate organ function. 9) No blood transfusion within 14 days prior to enrollment. 10) AE related to prior chemotherapy, radiation therapy or surgery must be Grade <= 1 according to CTCAE. (except alopecia, peripheral sensory neuropathy, skin hyperpigmentation and dysgeusia) 11) Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment. 12) Adequate oral intake. 13) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Administration of chemotherapy within 2 weeks prior to enrollment. 2) Major surgery or radiation therapy within 4 weeks prior to enrollment. Except bowel bypass surgery or enterostomy has passed over 2 weeks. 3) Investigational drugs were administrated within 4 weeks prior to enrollment. 4) Prior chemotherapy with TAS-102. 5) Known hypersensitivity to TAS-102 or excipients. 6) Patients with CNS metastases. 7) Malignant pleural effusion, ascites or cardiac effusion requiring invasive treatment. (such as ascites drainage) 8) Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma. 9) Any severe and/or uncontrolled medical conditions. 10) Positive HBs antigen or HCV antibody. Known positive serology for HIV. 11) Chronic treatment with steroids or another immunosuppressive agent. 12) Not use adequate methods of contraception. (duplex barrier method or intrauterine device) 13) Patient is unwilling or unable to comply with the protocol. 14) Patient is judged by the investigator to be inappropriate for study participation for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate (RR) Progression free survival (PFS) Overall survival (OS) Adverse events PK parameter | — |
Countries
Japan
Contacts
Public ContactHideaki, BANDO, M.D.
National Cancer Center Hospital East Gastrointestinal Oncology Division
Outcome results
None listed