Tamoxifen in Treating Patients With Metastatic Bladder Cancer That Did Not Respond to Previous Chemotherapy

  • STATUS
    Recruiting
  • participants needed
    75
  • sponsor
    Baylor College of Medicine
Updated on 7 November 2020
tumor cells

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 IdentifierNCT00589017
SponsorBaylor College of Medicine
Last Modified on7 November 2020

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