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

UMIN ID: C000000282

Registered date:14/11/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: unresectable or recurrent gastric cancer
• Date of first enrollment: 2003/12/01
• Target sample size: 52
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

S-1 is administered orally at the dose of 40mg/m2 twice a day for 28 days, followed by 14 days rest.
Cisplatin is administered intravenously twice a week for 4 weeks, followed by 2 weeks rest.
The doses of cisplatin
1)7.5mg/m2/day x 2/week
2)10mg/m2/day x 2/week
3)15mg/m2/day x 2/week

Outcome(s)

• Primary Outcome: adverse events, anti-tumor effect

Secondary Outcome

pharmacokinetics of cisplatin,
overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer
• Source(s) of Monetary Support: Japanese Foundation for Multidisciplinary Treatment of Cancer