Houston, Texas 77030

  • Bladder Cancer


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.


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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

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

Official Title:

Phase II Study of Tamoxifen for Progressive Metastatic Bladder Cancer Following Previous Platinum-Based Chemotherapy

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:


Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:July 2005
Primary Completion Date:July 2010
Primary Completion Type:Anticipated
Verification Date:July 2009
Last Changed Date:July 7, 2009
First Received Date:December 21, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:4-month freedom from progression (stable disease, partial response, or complete response)
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:tamoxifen citrate
Intervention Type:Other
Name:immunohistochemistry staining method
Intervention Type:Other
Name:laboratory biomarker analysis

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Baylor College of Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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