Tamoxifen in Treating Patients With Metastatic Bladder Cancer That Did Not Respond to Previous Chemotherapy
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- STATUS
- Recruiting
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- participants needed
- 75
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- sponsor
- Baylor College of Medicine
Summary
RATIONALE: Tamoxifen may slow the growth of tumor cells and may be an effective treatment for patients with metastatic bladder cancer that did not respond to previous chemotherapy. PURPOSE: This phase II trial is studying how well tamoxifen works in treating patients with metastatic bladder cancer that did not respond to previous chemotherapy.
Description
OBJECTIVES: Primary - To assess the 4-month freedom from progression in patients with progressive metastatic transitional cell carcinoma of the bladder treated with tamoxifen citrate. Secondary - 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 months.
Details
| Condition | bladder cancer, bladder cancer, Bladder Carcinoma, Urothelial Cancer |
|---|---|
| Treatment | laboratory biomarker analysis, immunohistochemistry staining method, tamoxifen citrate |
| Clinical Study Identifier | NCT00589017 |
| Sponsor | Baylor College of Medicine |
| Last Modified on | 7 November 2020 |
Eligibility
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