A phase II study of 2-methoxyestradiol nanocrystal colloidal dispersion alone and in combination with sunitinib malate in patients with metastatic renal cell carcinoma progressing on sunitinib malate.
Summary of "A phase II study of 2-methoxyestradiol nanocrystal colloidal dispersion alone and in combination with sunitinib malate in patients with metastatic renal cell carcinoma progressing on sunitinib malate."
Background Current treatment for metastatic renal cell cancer with vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKI) have provided improved overall survival, but complete responses are rare. We conducted a multicenter phase II study to evaluate the objective response rate of 2-methoxyestradiol (2ME2 NCD) alone and in combination with sunitinib for patients with metastatic renal cell carcinoma who have progressed on sunitinib alone. Methods Adults with metastatic kidney cancer were stratified depending on whether they were still taking sunitinib or had discontinued sunitinib therapy at the time of registration. Patients were treated with 2ME2 NCD alone or in combination with sunitinib. The primary endpoint was objective response rate. Results In total, 17 patients were enrolled, and 12 were evaluable for response (arm A, n = 7; arm b, n = 5). In arm A, four patients had the best response of stable disease, and three patients developed disease progression. In arm B, three patients had a best response of stable disease, and two patients had disease progression. One patient continued to receive treatment for a total of 14 cycles before developing disease progression. Fatigue was the most common observed toxicities. Thirty five percent of patients required discontinuation of therapy secondary to toxicities. Conclusions 2ME2 NCD had minimal anti-tumor activity, with no observed objective responses. The study was terminated because 2ME2 NCD was not found to be tolerable at the recommended phase 2 dose in this patient population. A newer 2ME2 analog is in development with a more favorable toxicity profile and increased potency.
Section of Hematology/Oncology, University of Wisconsin Carbone Cancer Center, Wisconsin Institutes for Medical Research, Room 7105, 1111 Highland Avenue, Madison, WI, 53705, USA, email@example.com.
This article was published in the following journal.
Name: Investigational new drugs
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21174224
- DOI: http://dx.doi.org/10.1007/s10637-010-9618-9
Medical and Biotech [MESH] Definitions
Colloids with liquid continuous phase and solid dispersed phase; the term is used loosely also for solid-in-gas (AEROSOLS) and other colloidal systems; water-insoluble drugs may be given as suspensions.
Vaginal Creams, Foams, And Jellies
Medicated dosage forms for topical application in the vagina. A cream is a semisolid emulsion containing suspended or dissolved medication; a foam is a dispersion of a gas in a medicated liquid resulting in a light, frothy mass; a jelly is a colloidal semisolid mass of a water soluble medicated material, usually translucent.
Optical Rotatory Dispersion
The method of measuring the dispersion of an optically active molecule to determine the relative magnitude of right- or left-handed components and sometimes structural features of the molecule.
The interval between two successive CELL DIVISIONS during which the CHROMOSOMES are not individually distinguishable. It is composed of the G phases (G1 PHASE; G0 PHASE; G2 PHASE) and S PHASE (when DNA replication occurs).
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