Los Angeles, California 90089


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma of the bladder - Evidence of progressive metastatic disease that is unresectable - Stage T4b, N1-3, or M1 disease - Must have received 1-2 prior systemic therapy regimens (chemotherapy, biological therapy, or both) that included at least one platinum-based chemotherapy regimen - Prior perioperative chemotherapy (adjuvant/neoadjuvant therapy) is considered one regimen - Bidimensionally measurable disease (including bone disease) of ≥ 10 mm on spiral CT scan or ≥ 20 mm on conventional CT scan - No uncontrolled CNS metastases - CNS metastases that have been previously treated with radiotherapy are allowed if patient is off corticosteroids PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Bilirubin ≤ 2.0 mg/dL - AST/ALT < 4 times upper limit of normal - Not pregnant - Negative pregnancy test - Fertile patients must use effective barrier or other nonhormonal methods of contraception - No New York Heart Association class III-IV cardiac disease (i.e., congestive heart failure or myocardial infarction within the past 6 months) - No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) - Not at high risk for deep vein thrombosis, as determined by the physician PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No more than 2 prior systemic therapy regimens, including chemotherapy and/or biological therapy - More than 4 weeks since prior systemic therapy - More than 2 weeks since prior major surgery


NCT ID:

NCT00589017


Primary Contact:

Study Chair
Seth P. Lerner, MD
Baylor College of Medicine


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90089
United States

Clinical Trials Office - USC/Norris Comprehensive Cancer Cente
Phone: 323-865-0451

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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