Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer Step 2: low dose cisplatin given twice a week + S-1
- Conditions
- unresectable or recurrent gastric cancer
- Registration Number
- JPRN-C000000282
- Lead Sponsor
- Japanese Foundation for Multidisciplinary Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 52
1) Histologically or cytologically demonstrated unresectable or recurrent gastric cancer
2) With measurable or assessable legion(s)
3) Without prior anti-tumor therapy. Hormone therapy and/or immunotherapy within two weeks prior to enrollment are eligible. Postoperative adjuvant therapy not containing CDDP within one month prior to enrollment is eligible.
4) Adequate bone marrow, hepatic and renal function
(1)Hb >= 9.0 g/dl
(2)WBC 4,000 - 12,000/mm3
(3)neutrophils >= 2,000/mm3
(4)platelets >= 100,000/ mm3
(5)T-Bil <= 1.5mg/dl
(6)GOT, GPT <= 2.5 times of normal upper limits
(7)Al-p <= 2 times of normal upper limits
(8)BUN <= normal upper limits
(9)Cr<= normal upper limits
(10)CCr >= 50ml/min
5) ECOG performance status (PS) 0 to 1
6) Life expectancy longer than 3 months
7) Oral intake is possible
8) Written informed consent
1) severe complication(s)
2) symptomatic brain metastases
3) active double cancers
4) women who are currently pregnant, nursing, or plan to become pregnant
5) cases where the investigator disapproved of participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method