advanced gastric cancer
Conditions
Interventions
SAPS 8 g a day are orally-administered daily in a 14-day period. The maximum dose is 16 g a day.
Sponsors
National Cancer Center Hospital East
School of Medicine, Keio University RIKEN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma. 2) Preserved tumor specimen or biopsy specimens are available before this therapy, and biopsy specimens are considered to be available after 1 course of this therapy. 3) Prior chemotherapies for advanced gastric cancer and recurrent gastric cancer meet the criteria 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 regimen.) i. Chemotherapy include fluorinated pyrimidine. ii. Chemotherapy include platinum derivative. iii. Chemotherapy include taxane. iv. Chemotherapy include Irinotecan. 4) >= 20 years old. 5) ECOG Performance Status of 0-1, or 2. 6) Adequate organ function. i.e. meet all criterion as follows. i. Absolute neutrophil count >= 1,500 /mm3 ii. hemoglobin >= 8.0 g/dL iii. Platelet count >= 75,000 /mm3 iv. Total bilirubin <= 2.0 mg/dL v. AST <= 100 IU/L or <= 150 IU/L with liver metastasis. vi. ALT <= 100 IU/L or <= 150 IU/L with liver metastasis. vii. serum creatinine <= 2.0 mg/dL 7) No blood transfusion within 14 days prior to enrollment. 8) AE related to prior treatment must be Grade <= 1 according to CTCAE. (except alopecia, peripheral sensory neuropathy, skin hyperpigmentation and dysgeusia) 9) Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment. 10) Adequate oral intake. 11) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Chemotherapy, radiation therapy or other investigational drugs within 2 weeks prior to enrollment. 2) Active bleeding. 3) Patient with any of the following symptoms within 6 months prior to administration of the drug; myocardial infarction, severe or unstable angina, congested heart failure, cerebrovascular accident containing transient ischemic attack or pulmonary embolism. 4) Uncontrolled bronchial asthma. 5) Patient with brain metastases. 6) Laparotomy or thoracotomy within 4 weeks to enrollment. 7) Known hypersensitivity to sulfa drugs or acetylsalicylic acid formulation. 8) Women during pregnancy or lactation, women suspected of being pregnant, women desiring future fertility. 9) Patient is judged by the investigator to be inappropriate for study participation for any reason. 10) Patient with Ulcerative colitis, or treated patient with sulfapyridine or 5-ASA derivative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of dose limiting toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event : AE Response rate: RR Progression free survival: PFS pharmacokinetics: PK | — |
Countries
Japan
Contacts
Public ContactKouhei Shitara
National Cancer Center Hospital East Gastrointestinal Oncology Division
Outcome results
None listed