Unique ID issued by UMIN | C000000282 |
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Receipt number | R000000352 |
Scientific Title | 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 |
Date of disclosure of the study information | 2005/11/14 |
Last modified on | 2010/07/16 13:15:27 |
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
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
(JFMC27-9902 Step2)
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
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
(JFMC27-9902 Step2)
Japan |
unresectable or recurrent gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety of a newly scheduled combination therapy of S-1 with twice a week administration of low-dose cisplatin in patients with unresectable or recurrent gastric cancer, to determine the recommended dose (RD) and MTD, and to examine the efficacy of the treatment regimen at the RD.
Safety,Efficacy
Confirmatory
Explanatory
Phase I,II
adverse events, anti-tumor effect
pharmacokinetics of cisplatin,
overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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
52
1st name | |
Middle name | |
Last name | Kosei Hirakawa |
Osaka City University Graduate School of Medicine
Department of Surgical Oncology
1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
06-6645-3838
1st name | |
Middle name | |
Last name | Japanese Foundation for Multidisciplinary Treatment of Cancer |
Japanese Foundation for Multidisciplinary Treatment of Cancer
Office
TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan
03-5627-7594
http://www.jfmc.or.jp/
jfmc-dc@jfmc.or.jp
Japanese Foundation for Multidisciplinary Treatment of Cancer
Japanese Foundation for Multidisciplinary Treatment of Cancer
Non profit foundation
Japan
NO
2005 | Year | 11 | Month | 14 | Day |
Published
Completed
2003 | Year | 12 | Month | 19 | Day |
2003 | Year | 12 | Month | 01 | Day |
2009 | Year | 09 | Month | 01 | Day |
2005 | Year | 11 | Month | 14 | Day |
2010 | Year | 07 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000352
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