Status:
COMPLETED
A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is an open-label, single center, nonrandomized study, consisting of a dose-escalating phase I study in advanced solid cancer and a subsequent phase II study in metastatic gastric cancer. In...
Eligibility Criteria
Inclusion
- In phase I:histologically or cytologically confirmed advanced solid Cancer In phase II:histologically or cytologically confirmed metastatic gastric adenocarcinoma
- Age: over 18 years
- No prior chemotherapy or radiotherapy (including any adjuvant hemotherapy) in phase II portion Previous chemotherapy up to two regimens (including adjuvant chemotherapy) is allowed in phase I portion; patients are required to have discontinued chemotherapy, immunotherapy, and radiotherapy for at least 4 weeks before entry into phase I portion
- Disease status must be that of measurable disease defined as: Lesions that can be accurately measured in at least one dimension \>10 mm with spiral CTscan and palpable LN (including supraclavicular LN) in physical examination.
- Performance status: ECOG 0-2
- Adequate major organ function including the following Hematopoietic function: WBC\>4,000/mm3 or ANC\> 2,000/mm3, Platelet count ³ 100,000/mm3Hepatic function: Bilirubin UNL (Upper normal limit), AST/ALT levels 2.5X UNL Renal function: Creatinine UNL
- Patients should sign an informed consent
Exclusion
- Inadequate cardiovascular function: New York Heart Association class III or IV heart disease Active angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significantconduction system abnormality
- Other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Pregnant or nursing women
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- Psychiatric disorder that would preclude compliance
- Patients receiving a concomitant treatment with drugs interacting with S-1 or docetaxel: flucytosine, phenitoin, warfarin et al.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00980382
Start Date
September 1 2004
End Date
August 1 2007
Last Update
September 21 2009
Active Locations (1)
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1
National Cancer Center Korea
Goyang-si, Gyeonggi-do, South Korea