Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00209651|
Recruitment Status : Unknown
Verified October 2007 by Hokkaido Gastrointestinal Cancer Study Group.
Recruitment status was: Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : November 1, 2007
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Campto, Topotesin Drug: TS-1||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302|
|Study Start Date :||January 2004|
|Estimated Study Completion Date :||December 2007|
Irinotecan and S-1
Drug: Campto, Topotesin
q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.
Other Name: irinotecanDrug: TS-1
80 mg/m2, PO (oral) on day 1~14 of each 28 day cycle.
Other Name: S-1
- objective tumor response [ Time Frame: 1-year ]
- Response duration, time to progression, overall survival, and safety will also be assessed. [ Time Frame: 2-years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209651
|Hokkaido University Hospital|
|Sapporo, Hokkaido, Japan, 060-8638|
|Study Chair:||Yoshito Komatsu, MD.PhD||Hokkaido Gastrointestinal Cancer Study Group|