IRESSA™ In Combo With Xeloda™ in Advanced Colorectal Cancer Patients After 1st-Line Chemo Failure
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|ClinicalTrials.gov Identifier: NCT00242788|
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : April 23, 2009
The primary objective of the Phase I part of the study is to determine the recommended dose of capecitabine to be administered in combination with ZD1839 250 mg orally once daily in subjects with advanced or metastatic colorectal cancer by assessing DLTs.
The primary objective of the Phase II part of the study is to estimate the objective response rate (complete response [CR] and partial response [PR]) at study closure for ZD1839 administered in combination with capecitabine in subjects with advanced or metastatic colorectal cancer using the Response Evaluation Criteria in Solid Tumours (RECIST).
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Gefitinib and capecitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Multicentre Clinical Study Of ZD1839 (Iressa™) In Combination With Capecitabine (Xeloda™) In Subjects With Advanced Colorectal Carcinoma After Failure Of First-Line Chemotherapy|
|Study Start Date :||February 2004|
|Actual Study Completion Date :||November 2005|
- Objective tumour response (CR and PR) at study closure based on the RECIST
- Incidence of controlled disease (CR, PR and SD) at study closure
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): NCT00242788
|Study Director:||AstraZeneca Spain Medical Director, MD||AstraZeneca|