Gastric Cancer
Conditions
Interventions
CPT-11+CDDP CPT-11 60mg/m2 d1 CDDP 30mg/m2 d1 repeat every 2weeks until PD
CPT-11 alone CPT-11 150mg/m2 d1 repeat every 2weeks until PD
Sponsors
ECRIN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically proven primary gastric adenocarcinoma. (2) No previous chemotherapy (except S-1 monotherapy), immunotherapy, or radiotherapy (including local irradiation for pain control). (3) Received S-1 monotherapy and match either of criteria <1> or <2> mentioned below. Patients who have discontinued treatment because of adverse events were excluded. <1> Tumor progression after at least 1 cycle of S-1 monotherapy (oral administration of S-1 for 4 weeks or more) given as initial chemotherapy (patients with progressive disease: PD). <2> Received at least 2 cycles of S-1 monotherapy (oral administration of S-1 for 8 weeks or more) as postoperative adjuvant chemotherapy and have suffered recurrence during treatment or within 6 months after the completion of treatment (patients with recurrence). (4) Previous S-1 monotherapy completed at least 2 weeks before. (5) Previous surgery completed at least 4 weeks before. (6) Performance status of 0-1 (ECOG classification). (7) Age over 20 years old. (8) More than 12 weeks of expected survival. (9) Adequate organ function. * WBC >=;4,000/mm3 and=<;12,000 mm3. * Neutrophil count >=2,000/mm3. * Platelet count>=;100,000/mm3. * Hemoglobin>=;8.0 g/dL Liver function tests * AST (GOT) and ALT (GPT)=<;100 IU/L. * Total bilirubin=<;1.50 mg/dL. Renal function test * Serum creatinine=<;1.20 mg/dL. (10) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Blood transfusion, blood products, or hematopoietic factor products, such as G-CSF, within 14 days before enrollment of this study. (2) Present and/or drug hypersensitivity or severe drug allergy. (3) Active double cancer. (4) With uncontrolled pleural effusion or ascites. (5) With pericardial effusion. (6) With infectious disease which needs treatment. (7) With symptomatic brain metastasis. (8) With marked ECG abnormalities. (9) With serve heart diseases, such as congestive heart failure, symptomatic coronary artery disease, inadequately controlled arrhythmia, myocardial infarction during the previous 12 months, etc. (10) With severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema, etc.). (11) With fresh gastrointestinal hemorrhage. (12) Watery stool (diarrhea). (13) Intestinal paralysis or ileus. (14) With a history of central nervous system disorder. (15) With senile dementia. (16) With psycologic disorder which disturbs recruiting to the study (17) Uncontrolled diabetes mellitus. (18) Receiving atazanavir sulfate. (19) Pregnant and/or nursing women. (20) Inappropriate recruit to the study judged by an investigator in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| time to treatment failure (TTF), response rate, safety (frequency and severity of adverse events) | — |
Countries
Japan
Outcome results
None listed