Patients with unresctable or recurrent gastric cancer.
Conditions
Interventions
Capecitabine plus fractional cisplatin: Level 1 Capecitabine:2,000mg/m2/day p.o.(day1-15) Cisplatin:15mg/m2 i.v. (day1, 8, 15) to be repeated every 3 weeks. Cisplatin is administered with
Sponsors
Department of Surgery, School of Medicine, Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histological confirmation of gastric adenocarcinoma. (2) Patients with an advanced or recurrent gastric cancer with estimative lesion, and had received no previous chemotherapy. i) Patients with unresectable gastric cancer who had not received any intervention except surgical procedure. ii) Patients with recurrent gastric cancer who had not been treated by any therapy against for the recurrent site. (3) Patient who are possible to be orally administrated capecitabene. (4) Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 - 1. (5) 20 years old or more,and 74 years old or less when received informed consent. (6) Written informed consent. (7) Life expectancy estimate 3 months, and more. (8) Vital organ functions (listed below) are preserved within 14 days prior to entry. i) White blood cell count >= 4,000/mm3 Neutrophils>=2,000/mm3 ii) Platelets>=100,000/mm3 iii).Hemoglobin>=9.0 g/dl iv).Total bilirubin<=1.5 mg/dl v). AST and ALT <= 100 I/U vi). Serum albumin >= 2.5 g/dl vii). Serum creatinine <= 1.2 mg/dl or estimated creatinine clearance rate ( Cockcroft-Gault formula) >= 60 mL/min
Exclusion criteria
Exclusion criteria: (1) Patients who had previously received chemotherapy including a fluorouracil-based regimen at least 6 month before registration. (2) Patients who had previously received chemotherapy including a Platinum-based regimen. (3) Patients with history of severe adverse event suspected to be caused by dihydropyrimidine dehydrogenase (DPD) deficiency. (4) Patients who have history of active simultaneous or metachronous double cancers within 5 year. However, patient with carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer. (5) Patients With severe or uncontrolled complication (infection, pulmonary fibrosis, intestinal paralysis, intestinal obstruction, uncontrolled diabetes mellitus, liver cirrhosis, history of myocardial infarction within 6 month, unstable angina, and so on.) (6) Patients with pericardial fluid or massive pleural or peritoneal fluid that required drainage. (7) Patients with CNS metastases only. (8) Patients with gastrointestinal bleeding which require a repeat blood transfusion. (9) Patient who have been treated with antipsychotic drugs, or patient with mental disorder requiring medication. (10) Patient with recurrent gastric cancer have had history of severe diarrhea (>=Grade 3) in previous adjuvant chemotherapy. (11) Patients with diarrhea (increase of 4 and more stool frequency per day over baseline or watery stool ) at registration. (12) Patients who have been treated with antithrombotic drug or drugs affected to coagulation and fibrinolytic system within 2 weeks before registration by the physician decision (Except for low-dose of aspirin). (13) Patients who are pregnant women, possibly pregnant women, willing to become pregnant, and nursing mothers. (14) Patients who have condition corresponding with contraindication for the administration of Capecitabine and Cisplatin. (15) Patients who are inappropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response rate Exploring several predictable biomarkers | — |
Countries
Japan
Contacts
Public ContactTsunehiro Takahashi
School of Medicine, Keio University Department of Surgery
Outcome results
None listed