Colorectal Neoplasm Clinical Trial
— TIROXOfficial title:
A Phase I and Pharmacokinetic Study of S-1 Combined With Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
Verified date | July 2007 |
Source | National Cancer Center, Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
This study is an open-label, single center, and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma.
Status | Active, not recruiting |
Enrollment | 23 |
Est. completion date | December 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically confirmed unresectable or metastatic colorectal or gastric carcinoma - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Measurable disease, according to the RECIST criteria or non-measurable disease Measurable lesions - Previous adjuvant, palliative chemotherapy including 5-FU, oxaliplatin and irinotecan, molecular targeted therapy and/or radiotherapy is allowed - Adequate major organ functions - Patients should sign a written informed consent before study entry Exclusion Criteria: - Prior history of peripheral neuropathy - Inadequate cardiovascular - Serious concurrent infection or nonmalignant illness - Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix - Psychiatric disorder that would preclude compliance - Pregnant, nursing women or patients with reproductive potential without contraception - Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center Korea | Goyang | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity measured by NCICTC v.3 | During treatment | ||
Primary | Blood level of irinotecan and S-1 and their metabolites | At 1st cycle | ||
Secondary | Maximal response rate, progression-free survival, survival |
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