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A Study of Oraxol® in Gastric Cancer Patients
Conditions
Advanced Metastatic Gastric Cancer - Recurrent Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Oraxol®, oral paclitaxel, paclitaxel, HM30181A, MTD, DLT, RD
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Paclitaxel
Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI)
2. Advanced/metastatic/recurred gastric cancer(PhaseII)
3. ECOG performance status ≤ 2
4. 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 Criteria:
1. 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)
2. Patients who have received bone marrow transplant or are to receive bone marrow transplant.
3. 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.
1. Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI)
2. Advanced/metastatic/recurred gastric cancer(PhaseII)
3. ECOG performance status ≤ 2
4. 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 Criteria:
1. 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)
2. Patients who have received bone marrow transplant or are to receive bone marrow transplant.
3. 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.
Locations
National Cancer Center
Goyang, Korea, Republic of
Seoul National University Hospital
Status: Recruiting
Contact: Sook Ryun Park, M.D, Ph.D
Seoul, Korea, Republic of
Status: Recruiting
Contact: Yung-Jue Bang, M.D, Ph.D
Start Date
May 2009
Completion Date
December 2012
Sponsors
Hanmi Pharmaceutical Company Limited
Source
Hanmi Pharmaceutical Company Limited
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page