drugset / Trial / NCT00242788
IRESSA™ In Combo With Xeloda™ in Advanced Colorectal Cancer Patients After 1st-Line Chemo Failure
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2004-02
- Primary completion
- —
- Completion
- 2005-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Gefitinib | Small molecule | 250 mg | Oral |