Status:
UNKNOWN
A Study of Oraxol® in Gastric Cancer Patients
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Advanced Metastatic Gastric Cancer
Recurrent Gastric Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.
Detailed Description
Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).
Eligibility Criteria
Inclusion
- Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI)
- Advanced/metastatic/recurred gastric cancer(PhaseII)
- ECOG performance status ≤ 2
- Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL \*AST/ALT/ALP ≤ 3 X the upper limit of normal but \<5 if liver or bone metastasis is present
Exclusion
- Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection)
- Patients who have received bone marrow transplant or are to receive bone marrow transplant.
- Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01491217
Start Date
May 1 2009
End Date
December 1 2012
Last Update
December 13 2011
Active Locations (2)
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1
National Cancer Center
Goyang, South Korea
2
Seoul National University Hospital
Seoul, South Korea