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Table 2

Ongoing Phase I/II trials of solid tumors at CWRU requiring sequential tumor biopsies for pharmacodynamic end points

TrialTumor typePharmacodynamic end points
Phase I pharmacodynamic trial of SU5416 Advanced solid tumors Microvessel density, apoptotic rate, and proliferative rate 
Phase Ib/II trial of SU5416 and doxorubicin in inflammatory breast cancer Inflammatory breast cancer Microvessel density, apoptotic rate, and proliferative rate 
Phase Ib/II trial of SU5416 and paclitaxel in head and neck cancer Head and neck cancer Microvessel density, apoptotic rate, and proliferative rate 
Phase I trial of fenretinide, cisplatin, and paclitaxel Advanced solid tumors Apoptosis, retinoid receptor function, and TIG3 expression 
Phase II trial of O6BG and BCNU in malignant melanoma Malignant melanoma Depletion of alkylguanine DNA alkyltransferase 
Phase I trial of CI-1033 Colon cancer Expression and activation of the epidermal growth factor receptor, ERK1/ERK2,a and AKT pathways 
TrialTumor typePharmacodynamic end points
Phase I pharmacodynamic trial of SU5416 Advanced solid tumors Microvessel density, apoptotic rate, and proliferative rate 
Phase Ib/II trial of SU5416 and doxorubicin in inflammatory breast cancer Inflammatory breast cancer Microvessel density, apoptotic rate, and proliferative rate 
Phase Ib/II trial of SU5416 and paclitaxel in head and neck cancer Head and neck cancer Microvessel density, apoptotic rate, and proliferative rate 
Phase I trial of fenretinide, cisplatin, and paclitaxel Advanced solid tumors Apoptosis, retinoid receptor function, and TIG3 expression 
Phase II trial of O6BG and BCNU in malignant melanoma Malignant melanoma Depletion of alkylguanine DNA alkyltransferase 
Phase I trial of CI-1033 Colon cancer Expression and activation of the epidermal growth factor receptor, ERK1/ERK2,a and AKT pathways 
a

ERK, extracellular signal-regulated kinase.

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