Phase II Study of Tamoxifen for Progressive Metastatic Bladder Cancer Following Previous Platinum-Based Chemotherapy
- To assess the 4-month freedom from progression in patients with progressive metastatic
transitional cell carcinoma of the bladder treated with tamoxifen citrate.
- To determine the objective response rate.
- To correlate response with estrogen-receptor status of the metastatic tumor.
- To collect data on the toxicity and safety profile of this regimen.
- To assess the overall survival.
OUTLINE: This is a multicenter study.
Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28
days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative
studies. Tumor tissue samples are analyzed for tumor estrogen receptors a and b by
immunohistochemical (IHC) staining. Tumor tissue and blood samples are stored for future
correlative biomarker studies.
After completion of study treatment, patients are followed every 2 months for up to 6
Primary Purpose: Treatment
4-month freedom from progression (stable disease, partial response, or complete response)
Seth P. Lerner, MD
Baylor College of Medicine
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Veterans Affairs Medical Center - Houston||Houston, Texas 77030|
|Methodist Hospital||Houston, Texas 77030|
|Dan L. Duncan Cancer Center at Baylor College of Medicine||Houston, Texas 77030|