This trial will assess the anti-tumor activity of low dose weekly Taxotere in patients with metastatic melanoma. Melanoma is a disease for which effective therapy does not exist for the majority of patients. Recent studies assessing the activity of standard chemotherapy agents demonstrates that the response rate for DTIC is -10% with median survials of between 4-6 months. Immunotherapy and biochemotherapy offer some patients an improved long-term outcome though these options are available only for those patients who are extremely healthy and have relatively slow-growing disease. Melanoma is a highly vascular tumor and evidence exists that angiogenesis plays a significant role in the progression of the disease. Taxotere is a novel taxane that has been shown to have modest anti-tumor activity in melanoma when administered every three weeks. Recent studies in our lab have demonstrated the TXT has anti-angiogenic activity at concentrations lower than that required for cytotoxicity. We propose to study the anti-tumor activity of lower dose weekly TXT in patients with melanoma. We will assess the PK profile of TXT as well as a series of anti-angiogenic surrogate studies to determine whether this agent has clinically meaningful anti-angiogenic activity.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000750-28
Application #
6411928
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1976-12-01
Project End
2004-11-30
Budget Start
Budget End
Support Year
28
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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