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Table 2

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

Trial	Tumor type	Pharmacodynamic 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

Trial	Tumor type	Pharmacodynamic 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.