advanced gastric cancer
Conditions
Interventions
CDDP 60mg/m2 is administrated on day1 and SAPS 6 g /day are orally-administered daily in day 1-14. The maximum dose is 8 g a day. 1 cycle is 21days until progressive disease.
Sponsors
National Cancer Center Hospital East
School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma. 2)Archival tumor specimen with CD44v positive before this therapy, and biopsy specimens are considered to be available before and after 1 course of this therapy. 3)Disease progression during or within 3 months after prior chemotherapy including cisplatin 4)>= 20 years old. 5)ECOG Performance Status of 0-1, or 2. 6)Adequate organ function. i.e. meet all criterion as follows. Absolute neutrophil count>=1,500 /mm3 Hemoglobin >=8.0 g/dL Platelet count>=75,000 /mm3 Total bilirubin <= 2.0 mg/dL AST<=100 IU/L or <=150 IU/L with liver metastasis. ALT<=100 IU/L or <=150 IU/L with liver metastasis. Serum creatinine<=2.0 mg/dL or Creatinine clearance >=50 mL/min 7)No blood transfusion within 8 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)Known history of serious adverse events due to cisplatin 9)Women during pregnancy or lactation, women suspected of being pregnant, women desiring future fertility. 10)Patient is judged by the investigator to be inappropriate for study participation for any reason. 11)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 | — |
Countries
Japan
Contacts
Public ContactKohei Shitara
National Cancer Center Hospital East Gastrointestinal Oncology Division
Outcome results
None listed