Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00506168|
Recruitment Status : Terminated (The study drugs are not covered anymore by insurance.)
First Posted : July 25, 2007
Last Update Posted : July 25, 2007
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms Secondary Drug Therapy, Combination||Drug: Irinotecan, Capecitabine||Phase 2|
This is a single center, single arm, open-label, phase II study to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.
Patients younger then 65 will be treated with irinotecan 100 mg/m2 on day 1 and 8 and capecitabine 1,000mg/m2 twice daily from day 1 to 14 every 3 weeks.For patiens equal to or older then 65, doses of irinotecan and capecitabine will be reduced to 60 mg/m2 and 750 mg/2, respectively.
Response assessment will be performed every 3 cycles of chemotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer|
|Study Start Date :||November 2001|
|Actual Study Completion Date :||July 2007|
- Maximal response rate and toxicities [ Time Frame: During treatment ]
- Progression-free survival and overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506168
|Korea, Republic of|
|National Cancer Center Korea|
|Goyang, Gyeonggi, Korea, Republic of, 410-769|
|Principal Investigator:||Kyung Hae Jung, M.D.|