Unique ID issued by UMIN | UMIN000015595 |
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Receipt number | R000017850 |
Scientific Title | Phase 1 study of cisplatin + sulfasalazine in patients with advanced gastric cancer. |
Date of disclosure of the study information | 2014/11/04 |
Last modified on | 2016/04/12 08:48:45 |
Phase 1 study of cisplatin + sulfasalazine in patients with advanced gastric cancer.
CDDP+SASP
Phase 1 study of cisplatin + sulfasalazine in patients with advanced gastric cancer.
CDDP+SASP
Japan |
advanced gastric cancer
Gastroenterology |
Malignancy
NO
To determine a recommend dose of CDDP+SASP in CD44v positive patients with advanced gastric cancer.
Safety
Frequency of dose limiting toxicity (DLT)
Adverse event : AE
Response rate: RR
Progression free survival: PFS
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
CDDP 60mg/m2 is administrated on day1 and SAPS 6 g /day are orally-administered daily in day 1-14. The maximum dose is 8 g a day.
1 cycle is 21days until progressive disease.
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma.
2)Archival tumor specimen with CD44v positive before this therapy, and biopsy specimens are considered to be available before and after 1 course of this therapy.
3)Disease progression during or within 3 months after prior chemotherapy including cisplatin
4)>= 20 years old.
5)ECOG Performance Status of 0-1, or 2.
6)Adequate organ function. i.e. meet all criterion as follows.
Absolute neutrophil count>=1,500 /mm3
Hemoglobin >=8.0 g/dL
Platelet count>=75,000 /mm3
Total bilirubin <= 2.0 mg/dL
AST<=100 IU/L or <=150 IU/L with liver metastasis.
ALT<=100 IU/L or <=150 IU/L with liver metastasis.
Serum creatinine<=2.0 mg/dL or Creatinine clearance >=50 mL/min
7)No blood transfusion within 8 days prior to enrollment.
8)AE related to prior treatment must be Grade <= 1 according to CTCAE. (except alopecia, peripheral sensory neuropathy, skin hyperpigmentation and dysgeusia)
9)Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment.
10)Adequate oral intake.
11)Written informed consent.
1)Chemotherapy, radiation therapy or other investigational drugs within 2 weeks prior to enrollment.
2)Active bleeding.
3)Patient with any of the following symptoms within 6 months prior to administration of the drug;myocardial infarction, severe or unstable angina, congested heart failure,cerebrovascular accident containing transient ischemic attack or pulmonary embolism.
4)Uncontrolled bronchial asthma.
5)Patient with brain metastases.
6)Laparotomy or thoracotomy within 4 weeks to enrollment.
7)Known hypersensitivity to sulfa drugs or acetylsalicylic acid formulation.
8)Known history of serious adverse events due to cisplatin
9)Women during pregnancy or lactation, women suspected of being pregnant, women desiring future fertility.
10)Patient is judged by the investigator to be inappropriate for study participation for any reason.
11)Patient with Ulcerative colitis, or treated patient with sulfapyridine or 5-ASA derivative.
18
1st name | |
Middle name | |
Last name | Toshihiko Doi |
National Cancer Center Hospital East
Gastrointestinal Oncology Division
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
sasp_core@east.ncc.go.jp
1st name | |
Middle name | |
Last name | Kohei Shitara |
National Cancer Center Hospital East
Gastrointestinal Oncology Division
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
04-7133-1111
sasp_core@east.ncc.go.jp
National Cancer Center Hospital East
Health and Labor Sciences Research Grant
Japanese Governmental office
School of Medicine, Keio University
NO
国立がん研究センター東病院
2014 | Year | 11 | Month | 04 | Day |
Unpublished
Terminated
2014 | Year | 09 | Month | 28 | Day |
2014 | Year | 11 | Month | 15 | Day |
2014 | Year | 11 | Month | 04 | Day |
2016 | Year | 04 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017850
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