Phase I study of STZ plus S-1 for GEP-NET
- Conditions
- Gastroenteropancreatic Neuroendocrine Tumor
- Registration Number
- JPRN-jRCTs031180247
- Lead Sponsor
- Okusaka Takuji
- Brief Summary
The number of patients with DLT at STS therapy for advanced GEP-NET (G1, G2, G3) was 0 of 3 at dose level 1. Intracranial hemorrhage of Grade 5 occurred at dose level 2 (maximum dose), but it was judged no correlation with trial therapy, so this case was excluded from the DLT evaluation. In subsequent 3 cases at level 2, DLT did not occur. The recommended dose level was 2. DLT occurred 2 patients of 10 including the expansion cohort performed at dose level 2. The recommended dose was level 2 in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 14
1)Patient who was diagnosed gastroenteropancreatic neuroendocrine tumor (NET G1,G2,G3 from WHO 2010 classification)
2)1) and surgically non-resectable
3)Patient who underwent at least one or more regimen of systemic chemotherapy except streptozocin, fluorouracil related agents,and transcatheter arterial chemoembolization for liver metastasis.
4)ECOG Performance Status:0 or 1
5)Patient's laboratory results satisfy following criteria within 14 days before entry
hemoglobin level:more than 9.0g/dL
White blood cell:equal to or less than 12000/mm3
Neutrophil:more than 2000/mm3
Platelet:more than 100000/mm3
AST/ALT:equal to or less than 100 IU/L
(equal to or less than 150 IU/L when underwent biliary drainage or choledochojejunostomy)
Total bilirubin:equal to or less than 1.5 mg/dL(equal to or less than 2.0 mg/dL when underwent biliary drainage or choledochojejunostomy)
Creatinine:equal to or less than 1.2 mg/dL
Creatinine clearance:more than 60 mL/min(measured value or Cockcroft-Gault formula)
6)Patient is able to oral intake
1)Patient who has double or more active cancer
2)Patient who is at risk of becoming pregnant, or in pregnancy. Male patient who is desiring future fertility for partner.
3)Psychiatric patient
4)Patient treated with systemic administration of steroid
5)Patient with pulmonary fibrosis or interstitial pneumonia
6)Patient who has watery diarrhea
7)Patient with an infection (except viral hepatitis)
8)Patient who has a severe complication (cardiac failure, renal failure, hepatic failure, peptic ulcer hemorrhage, paralytic ileus, severe diabetes mellitus)
9)Patient who has a blood transfusion before entry within 14 days
10)Patient who has mild pleural effusion or ascites or cariac effusion on X-ray or ultrasonography
11)Patient who has severe cardiac disease
12)Patient who takes flucytosine, phenytoin or warfarin potassium
13)Patient who has brain metastasis
14)Patient who was judged inadequate to join the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method frequency of DLT
- Secondary Outcome Measures
Name Time Method overall survival(OS), progression-free survival(PFS), Response Rate(RR), frequency of adverse events